id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-1977-N-0025-0231,FDA,FDA-1977-N-0025,"Tentative Final Monographs: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Partial Withdrawal",Proposed Rule,Withdrawal,2018-05-14T04:00:00Z,2018,5,2018-05-14T04:00:00Z,,2018-05-14T20:35:15Z,2018-10194,0,0,0900006483262e32
FDA-1977-N-0025-0053,FDA,FDA-1977-N-0025,"Reference 45: Bergmann, J. F. et al., ""Endoscopic Evaluation of the Effect of Ketoprofen, Ibuprofen, and Aspirin on the Gastroduodenal Mucosa,"" European Journal of Clinical Pharmacology, 42:685, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:05:42Z,,0,0,09000064805da241
FDA-1977-N-0025-0048,FDA,FDA-1977-N-0025,"Reference 56: Mclntire, S. C. et al, ""Acute Flank Pain and Reversible Renal Dysfunction Associated with Nonsteroidal Anti-inflammatory Drug Use,"" Pediatrics, 92:459-460, 1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:36:13Z,,0,0,09000064805da234
FDA-1977-N-0025-0193,FDA,FDA-1977-N-0025,Table of Contents re: Comment from Wyeth Consumer Healthcare,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-04-05T19:45:44Z,,0,0,09000064805da2ca
FDA-1977-N-0025-0185,FDA,FDA-1977-N-0025,Appendix II re: Monograph Response re: Comment from Wyeth Consumer Healthcare,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-04-05T20:13:23Z,,0,0,09000064805da2d2
FDA-1977-N-0025-0230,FDA,FDA-1977-N-0025,Tab 5. Reference List re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-21T13:12:43Z,,0,0,09000064805da2e1
FDA-1977-N-0025-0146,FDA,FDA-1977-N-0025,Background Material-Reference 9,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2018-01-02T19:17:49Z,,0,0,09000064805da29b
FDA-1977-N-0025-0139,FDA,FDA-1977-N-0025,"Reference 36: Gurwitz, J. H. et al., ""The Impact of Ibuprofen on the Efficacy of Antihypertensive Treatment with Hydrochlorthiazide in Elderly Patients,"" Journal of Gerontology. 51A: M74- M79, 1996 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:14:57Z,,0,0,09000064805da2a2
FDA-1977-N-0025-0101,FDA,FDA-1977-N-0025,"Reference 116: Bharija, S. C., and M. S. Belhaj, ""Fixed Drug Eruption on Three Independent Sites Induced by Three Chemically Unrelated Drugs,"" Dermatologica, 181:237, 1990 (letters) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:41:43Z,,0,0,09000064805da272
FDA-1977-N-0025-0166,FDA,FDA-1977-N-0025,"Reference 22: Adams, S. S., and J. Warwick-Buckler, ""Ibuprofen and Flurbiprofen,"" Clinics in Rheumatic Diseases. 5:359-379, 1979 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T13:40:18Z,,0,0,09000064805da2b1
FDA-1977-N-0025-0133,FDA,FDA-1977-N-0025,"Reference 43: Kaufman, D. W. et al., ""Nonsteroidal Anti-inflammatory Drug Use in Relation to Major Upper Gastrointestinal Bleeding,"" Clinical Pharmacology and Therapeutics. 53:485-494, 1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:48:58Z,,0,0,09000064805da2a8
FDA-1977-N-0025-0040,FDA,FDA-1977-N-0025,"Reference 62: Spierto, T. J., M. B. Kaufman, and C. A. Stoukedes., ""Acute Renal Failure Associated with the Use of Over-the-Counter Ibuprofen,"" The Annals of Pharmacotherapy, 26:714,1992 (letter) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:48:22Z,,0,0,09000064805da23c
FDA-1977-N-0025-0179,FDA,FDA-1977-N-0025,Request for Extension from Albemarle Corporation,Other,Request for Extension,2018-01-02T05:00:00Z,2018,1,2018-01-02T05:00:00Z,2002-11-20T04:59:59Z,2019-01-30T23:54:29Z,,0,0,09000064805da2d8
FDA-1977-N-0025-0038,FDA,FDA-1977-N-0025,"Reference 74: Deutsch P. H., and G. L. Mandell, ""Reversible Pelger-Huet Anomaly Associated with Ibuprofen Therapy,"" Archives of Internal Medicine, 145:166, 1985 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:20:54Z,,0,0,09000064805da22f
FDA-1977-N-0025-0016,FDA,FDA-1977-N-0025,"Reference 85: Butterfield J. H. et al., ""Severe Generalized Reactions to Ibuprofen: Report of a Case,"" Journal of Rheumatology, 13:649-650, 1986 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:45:58Z,,0,0,09000064805da21c
FDA-1977-N-0025-0071,FDA,FDA-1977-N-0025,"Reference 105: Bouland, D. L., N. L. Specht, and D. R. Hegstad, ""Ibuprofen and Aseptic Meningitis,"" Annals of Internal Medicine, 104:731, 1986 (letter) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:51:31Z,,0,0,09000064805da267
FDA-1977-N-0025-0111,FDA,FDA-1977-N-0025,"Reference 106: Davis, B. J. et al., ""Drug-Induced Aseptic Meningitis Caused by Two Medications,"" Neurology, 44:984-985,1994 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:53:21Z,,0,0,09000064805da268
FDA-1977-N-0025-0105,FDA,FDA-1977-N-0025,"Reference 112: Eustace, S., and B. Buff, ""Magnetic Resonance Imaging in Drug-Induced Meningitis,"" Canadian Association of Radiologists Journal, 45:463-465, 1994 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:30:17Z,,0,0,09000064805da26e
FDA-1977-N-0025-0219,FDA,FDA-1977-N-0025,Tab 10 re: Comment from Albemarle Corporation,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-22T14:51:33Z,,0,0,09000064805da2f2
FDA-1977-N-0025-0100,FDA,FDA-1977-N-0025,"Reference 117: Khan, A. R., ""Erythema Nodosum After Ibuprofen,"" British Medical Journal, 288:1048,1984 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:44:15Z,,0,0,09000064805da273
FDA-1977-N-0025-0023,FDA,FDA-1977-N-0025,"Reference 92: Ewert, B. H., ""Ibuprofen-Associated Meningitis in a Woman with Only Serologic Evidence of a Rheumatologic Disorder,"" The American Journal of Medical Sciences, 287:326-327, 1989 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:12:25Z,,0,0,09000064805da223
FDA-1977-N-0025-0018,FDA,FDA-1977-N-0025,"Reference 87: Ekert, F. et al, ""Anaphylactoid Reactions Due to Ibuprofen"" (abstract), Journal of Allergy and Clinical Immunology, 89:347, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:50:23Z,,0,0,09000064805da21e
FDA-1977-N-0025-0034,FDA,FDA-1977-N-0025,"Reference 76: Mathur, S. L., ""Ibuprofen in Bronchial Asthma,"" Journal of the Association of Physicians of India, 36:523, 1988 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:25:44Z,,0,0,09000064805da231
FDA-1977-N-0025-0092,FDA,FDA-1977-N-0025,"Reference 125: Kaplan, B. H. et al., ""Aseptic Meningitis and Iridocyclitis Related to Ibuprofen,"" American Journal of Ophthalmology, 117:119-120, 1994 (letters) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:07:43Z,,0,0,09000064805da27d
FDA-1977-N-0025-0126,FDA,FDA-1977-N-0025,"Reference 133: Minuz, P. et al., ""Amlodipine and Haemodynamic Effects of Cyclo-Oxygenase Inhibition,"" British Journal of Clinical Pharmacology, 39:45-50, 1995 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:28:42Z,,0,0,09000064805da285
FDA-1977-N-0025-0129,FDA,FDA-1977-N-0025,"Reference 130: Minuz, P. et al., ""Antihypertensive Activity of Enalapril. Effect of Ibuprofen and Different Salt Intakes,"" Journal of Clinical Hypertension, 3:645-653, 1987 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:26:20Z,,0,0,09000064805da282
FDA-1977-N-0025-0098,FDA,FDA-1977-N-0025,"Reference 119: Shelly, E. D., and W. B. Shelley, ""Ibuprofen Urticaria,"" Journal of the American Academy of Dermatology, 17:1057-1058, 1987 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:51:57Z,,0,0,09000064805da276
FDA-1977-N-0025-0069,FDA,FDA-1977-N-0025,"Reference 147: Giles, A. D. et al., ""A Single-Dose Assessment of an Ibuprofen/Codeine Combination in Post-Operative Dental Pain,"" International Journal of Oral Maxillofacillary Surgery, 15:727-732, 1986 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:03:55Z,,0,0,09000064805da251
FDA-1977-N-0025-0087,FDA,FDA-1977-N-0025,"Reference 153: Nebe, J., M. Heier, and H. C. Diener, ""Low-dose Ibuprofen in Self-Medication of Mild to Moderate Headache: A Comparison with Acetylsalicylic Acid and Placebo,"" Cephalalgia, 15:531-535,1995 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:18:25Z,,0,0,09000064805da256
FDA-1977-N-0025-0078,FDA,FDA-1977-N-0025,"Reference 98: Gilbert, G. J., and H. W. Eichenbaum, ""Ibuprofen-induced Meningitis in an Elderly Patient with Systemic Lupus Erythematosus,"" Southern Medical Journal 82:514-515, 1989 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:25:18Z,,0,0,09000064805da25f
FDA-1977-N-0025-0079,FDA,FDA-1977-N-0025,"Reference 97: Thilman, A. F. et al., ""Recurrent Aseptic Meningitis (Mollaret Meningitis)-Spontaneous and Drug-Induced Appearance,"" Fortschritte der Neurologie-Psychiatrie (Stuttgart), 59:493-497, 1991 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:22:23Z,,0,0,09000064805da25e
FDA-1977-N-0025-0073,FDA,FDA-1977-N-0025,"Reference 103: Van der Zwan, A., and J. G. Van Dam, ""Side Effects of Medicinal Agents-Ibuprofen Meningitis,"" Nederlands Tijdschrift voor Geneeskunde, 136:1613-1614, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:46:44Z,,0,0,09000064805da264
FDA-1977-N-0025-0125,FDA,FDA-1977-N-0025,"Reference 134: Pancera, P. et al., ""Changes in Peripheral Hemodynamics and Vasodilating Prostaglandins After High-dose Short-term Ibuprofen in Chronically Treated Hypertensive Patients,"" Prostaglandins, Leukotrienes and Essential Fatty Acids, 54:217-222, 1996 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:44:45Z,,0,0,09000064805da286
FDA-1977-N-0025-0117,FDA,FDA-1977-N-0025,Background Material-References to Appendix D,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-01-31T19:16:34Z,,0,0,09000064805da28e
FDA-1977-N-0025-0203,FDA,FDA-1977-N-0025,Tab 3. Comments on Proposed Rule 67 FR 54139 re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-21T13:09:29Z,,0,0,09000064805da2e0
FDA-1977-N-0025-0216,FDA,FDA-1977-N-0025,Tab 1 re: Comment from Albemarle Corporation,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-22T14:12:48Z,,0,0,09000064805da2ef
FDA-1977-N-0025-0222,FDA,FDA-1977-N-0025,Tab 6 re: Comment from Albemarle Corporation,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-22T14:24:45Z,,0,0,09000064805da2f5
FDA-1977-N-0025-0109,FDA,FDA-1977-N-0025,"Reference 108: Morgan, A., and D. Clark, ""CNS Adverse Effects of Nonsteroidal Anti-inflammatory Drugs,"" CNS Drugs, 4:281-290, 1998 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:17:27Z,,0,0,09000064805da26a
FDA-1977-N-0025-0088,FDA,FDA-1977-N-0025,"Reference 152: Schachtel, B. P., S. A. Furey, and W. R. Thoden, ""Nonprescription Ibuprofen and Acetaminophen in the Treatment of Tension-Type Headache,"" Journal of Clinical Pharmacology, 36:1120-1125,1996 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:15:38Z,,0,0,09000064805da255
FDA-1977-N-0025-0103,FDA,FDA-1977-N-0025,"Reference 114: Jensen, S. et al., ""Ibuprofen-induced Meningitis in a Male with Systemic Lupus Erythematosus,"" Acta Medica Scandinavica, 221:509-511, 1987 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:37:01Z,,0,0,09000064805da270
FDA-1977-N-0025-0097,FDA,FDA-1977-N-0025,"Reference 120: Ben-Chetrit, E., and A. Rubinow, ""Exacerbation of Psoriasis by Ibuprofen,"" Cutis. 38:45, 1986 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:54:49Z,,0,0,09000064805da278
FDA-1977-N-0025-0080,FDA,FDA-1977-N-0025,"Reference 96: Perera, D. R., A. K. Seiffert, and H. M. Greeley, ""Ibuprofen and Meningoencephalitis,"" Southern Medical Journal, 100:619, 1984 (letter) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:20:35Z,,0,0,09000064805da25d
FDA-1977-N-0025-0169,FDA,FDA-1977-N-0025,"Reference 19: Jamali, F. et al., ""Human Pharmacokinetics of Ibuprofen Enantiomers Following Different Doses and Formulations: Intestinal Chiral Inversion,"" Journal of Pharmaceutical Sciences. 81:221-225, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T13:32:48Z,,0,0,09000064805da2ae
FDA-1977-N-0025-0081,FDA,FDA-1977-N-0025,"Reference 159: Gaitonde, B. B., K. Dattani, and K. Morwani, ""Antipyretic Activity of Ibuprofen (Brufen),"" Journal of the re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T19:19:43Z,,0,0,09000064805da25c
FDA-1977-N-0025-0175,FDA,FDA-1977-N-0025,Reference from FDA,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-11T14:34:46Z,,0,0,09000064805da2c4
FDA-1977-N-0025-0116,FDA,FDA-1977-N-0025,Background Material-References to Appendix E,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2018-01-02T19:11:56Z,,0,0,09000064805da28f
FDA-1977-N-0025-0184,FDA,FDA-1977-N-0025,Appendix II re: Monograph Response re: Comment from Wyeth Consumer Healthcare,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-04-05T20:16:29Z,,0,0,09000064805da2d3
FDA-1977-N-0025-0115,FDA,FDA-1977-N-0025,Background Material-References to Appendix E (Cover Card),Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2018-01-02T19:11:56Z,,0,0,09000064805da290
FDA-1977-N-0025-0062,FDA,FDA-1977-N-0025,"Reference 37: Agency Letter to Prescription NSAID Manufacturers/Sponsors, in OTC Vol. 03BTFM (I), Docket No. 77N-094I, Dockets Management Branch re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:17:13Z,,0,0,09000064805da24a
FDA-1977-N-0025-0142,FDA,FDA-1977-N-0025,"Reference 33: Rudy, A. C. et al., ""Stereoselective Metabolism of Ibuprofen in Humans: Administration of R-, S- and Racemic ibuprofen,"" Journal of Pharmacology and Experimental Therapeutics. 259:1133-1139,1991 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:07:16Z,,0,0,09000064805da29f
FDA-1977-N-0025-0158,FDA,FDA-1977-N-0025,"Reference 30: Leeman, T. D. et al, ""A Major Role for Cytochrome P450TB (CYP23 Subfamily) in the Actions of Non-Steroidal Anti-inflammatory Drugs,"" Drugs Under Experimental and Clinical Research. 19:189-195,1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:01:13Z,,0,0,09000064805da2b9
FDA-1977-N-0025-0135,FDA,FDA-1977-N-0025,"Reference 41: Griffin, M. R. et al., ""Nonsteroidal Anti-inflammatory Drug Use and Increased Risk for Peptic Ulcer Disease in Elderly Persons,"" Annals of Internal Medicine. 114:257-263, 1991 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:36:08Z,,0,0,09000064805da2a6
FDA-1977-N-0025-0044,FDA,FDA-1977-N-0025,"Reference 58: Moss, A. H. et al., ""Over-the-Counter Ibuprofen and Acute Renal Failure,"" Annals of Internal Medicine, 105:303,1986 (letter) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:39:49Z,,0,0,09000064805da238
FDA-1977-N-0025-0050,FDA,FDA-1977-N-0025,"Reference 64: Sheiner, P. A. et al., ""Acute Renal Failure Associated with the Use of Ibuprofen in Two Liver Transplant Recipients on FK506,"" Transplantation, 57:1132-1133,1994 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:52:23Z,,0,0,09000064805da23e
FDA-1977-N-0025-0084,FDA,FDA-1977-N-0025,"Reference 156: Habib, S. et al., ""A Study of the Comparative Effectiveness of Four Common Analgesics in the Control of Post-Surgical Dental Pain,"" Oral Surgery, Oral Medicine, and Oral Pathology, 70:559-563,1990 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:24:31Z,,0,0,09000064805da259
FDA-1977-N-0025-0132,FDA,FDA-1977-N-0025,"Reference 127: Fitt, A., M. Dayan, and R. F. Gillie, ""Vortex Keratopathy Associated with Ibuprofen Therapy,"" Eye. 10:145-146, 1996 (letters) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:12:02Z,,0,0,09000064805da27f
FDA-1977-N-0025-0030,FDA,FDA-1977-N-0025,"Reference 69: Alam, I., L. D. Ferrell, and N. M. Bass, ""Vanishing Bile Duct Syndrome Temporally Associated with Ibuprofen Use,"" American Journal of Gastroenterology, 91:1626-1630, 1996 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:08:59Z,,0,0,09000064805da22a
FDA-1977-N-0025-0025,FDA,FDA-1977-N-0025,"Reference 94: Treves, R. et al., ""Aseptic Meningitis and Acute Renal Failure Induced by Ibuprofen During the Treatment of Systemic Lupus Erythematosus,"" Revue de Rheumatisme, 50:75-76, 1983 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:16:31Z,,0,0,09000064805da225
FDA-1977-N-0025-0074,FDA,FDA-1977-N-0025,"Reference 102: Mifsud, A. J., ""Drug-Related Recurrent Meningitis,"" Journal of Infection, 17:151- 153, 1988. re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:43:53Z,,0,0,09000064805da263
FDA-1977-N-0025-0228,FDA,FDA-1977-N-0025,Appendix A re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-11T13:17:26Z,,0,0,09000064805da2e3
FDA-1977-N-0025-0151,FDA,FDA-1977-N-0025,"Reference 5: Minutes of the Seventeenth Meeting of the Arthritis Advisory Committee, OTC Vol. 03BTFM(I), Docket No. 77N-094I, Dockets Management Branch re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T13:02:29Z,,0,0,09000064805da296
FDA-1977-N-0025-0140,FDA,FDA-1977-N-0025,"Reference 35: Walter, K., and C. Dilger, ""Ibuprofen in Human Milk,"" British Journal of Clinical Pharmacology. 44:211-212 1997 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:11:01Z,,0,0,09000064805da2a1
FDA-1977-N-0025-0137,FDA,FDA-1977-N-0025,"Reference 38: Motrin (prescription) Label, in Physicians' Desk Reference. 54th ed. Directory Services edited by David W. Sifton, Medical Economics Company, Inc., Montvale, NJ, pp 1684- 1687, 2000 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:24:54Z,,0,0,09000064805da2a4
FDA-1977-N-0025-0067,FDA,FDA-1977-N-0025,"Reference 43: Kaufman, D. W. et al., ""Nonsteroidal Anti-inflammatory Drug Use in Relation to Major Upper Gastrointestinal Bleeding,"" Clinical Pharmacology and Therapeutics. 53:485-494, 1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:44:07Z,,0,0,09000064805da24f
FDA-1977-N-0025-0058,FDA,FDA-1977-N-0025,"Reference 50: Farquhar, W. B. et al., ""Effects of Acetaminophen and Ibuprofen on Renal Function in the Stressed Kidney,"" Journal of Applied Physiology, 86:598-604, 1999 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:21:59Z,,0,0,09000064805da246
FDA-1977-N-0025-0045,FDA,FDA-1977-N-0025,"Reference 57: Wattad, A., et al., ""A Unique Complication of Nonsteroidal Anti-inflammatory Drug Use,"" Pediatrics. 93:693, 1993 (letter) re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:38:13Z,,0,0,09000064805da237
FDA-1977-N-0025-0099,FDA,FDA-1977-N-0025,"Reference 118: Laing, V. B., E. F. Sherertz, and F. P. Flowers., ""Pemphigold-like Bullous Eruption Related to Ibuprofen,"" Journal of the American Academy of Dermatology, 19:91-94, 1988 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:46:51Z,,0,0,09000064805da275
FDA-1977-N-0025-0096,FDA,FDA-1977-N-0025,"Reference 121: Pavithran, K., ""Exacerbation of Psoriasis by Ibuprofen,"" Indian Journal of Dermatology, Venereology, and Leprology. 53:372-373, 1987 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:57:20Z,,0,0,09000064805da279
FDA-1977-N-0025-0131,FDA,FDA-1977-N-0025,"Reference 128: Ridder III, W. H., and A. Tomlinson, ""Effect of Ibuprofen on Contrast Sensitivity,"" Optometry and Vision Science, 69:652-655, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T18:16:27Z,,0,0,09000064805da280
FDA-1977-N-0025-0122,FDA,FDA-1977-N-0025,"Reference 138: Cooper, S. A., ""Five Studies on Ibuprofen for Postsurgical Dental Pain (Study 5),"" American Journal of Medicine, 77:70-77, 1984 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T19:38:11Z,,0,0,09000064805da289
FDA-1977-N-0025-0029,FDA,FDA-1977-N-0025,"Reference 68: Fukui, M. et al., ""A Case of Drug-Induced Hepatitis with Multinuclear Giant Hepatic Cells in Adult,"" Kanzo. 26:500-505, 1985 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:07:00Z,,0,0,09000064805da229
FDA-1977-N-0025-0032,FDA,FDA-1977-N-0025,"Reference 71: Katz, L. M., and P. Y. Love, ""NSAIDs and the Liver,"" in Therapeutic Applications of NSAIDs (Chapter 12), edited by J. P. Famaey and H. E. Paulus, Marcel Dekker, Inc., New York, NY, pp. 247-263,1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:12:45Z,,0,0,09000064805da22c
FDA-1977-N-0025-0051,FDA,FDA-1977-N-0025,"Reference 65: Rault, R. M., ""Case Report: Hyponatremia Associated with Nonsteroidal Anti-inflammatory Drugs,"" American Journal of the Medical Sciences, 305:318-320, 1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:00:27Z,,0,0,09000064805da23f
FDA-1977-N-0025-0031,FDA,FDA-1977-N-0025,"Reference 70: Garcia-Rodriguez, L.A. et al., ""The Role of Non-Steroidal Anti-inflammatory Drugs in Acute Liver Injury,"" British Medical Journal, 305:865-868, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:10:39Z,,0,0,09000064805da22b
FDA-1977-N-0025-0077,FDA,FDA-1977-N-0025,"Reference 99: Hanson, L., and H. J. Morgan, ""Ibuprofen-induced Aseptic Meningitis,"" Journal of Tennessee Medical Association, 87:58, 1994 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:38:15Z,,0,0,09000064805da260
FDA-1977-N-0025-0072,FDA,FDA-1977-N-0025,"Reference 104: Chez, M. et al., ""Ibuprofen-lnduced Meningitis: Detection of Intrathecal IgG Synthesis and Immune Complexes,"" Neurology, 39:1578-1580, 1989 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T15:49:18Z,,0,0,09000064805da265
FDA-1977-N-0025-0212,FDA,FDA-1977-N-0025,Table of Contents re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-01-31T20:11:05Z,,0,0,09000064805da2eb
FDA-1977-N-0025-0190,FDA,FDA-1977-N-0025,Appendix I re: Comment from Wyeth Consumer Healthcare,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-04-05T19:48:47Z,,0,0,09000064805da2cd
FDA-1977-N-0025-0177,FDA,FDA-1977-N-0025,Background Material,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2018-01-02T19:25:09Z,,0,0,09000064805da2bf
FDA-1977-N-0025-0037,FDA,FDA-1977-N-0025,"Reference 75: Wittkowsky, A. K., ""Thrombosis,"" Applied Therapeutics: The Clinical Use of Drugs, 6th ed., edited by Young, L. Y., and M. A. Koda-Kimble, Applied Therapeutics, Inc., Vancouver, WA, pp. 12-20-12-21, 1995 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:23:06Z,,0,0,09000064805da230
FDA-1977-N-0025-0035,FDA,FDA-1977-N-0025,"Reference 77: Ayers, J. G., D. M. Flemming, and R. M. Whittington, ""Asthma Death Due to Ibuprofen,"" Lancet, 1:1082, 1987 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:27:22Z,,0,0,09000064805da232
FDA-1977-N-0025-0011,FDA,FDA-1977-N-0025,"Reference 80: Jamil, A. S., and F. S. Majid, ""Life-Threatening Bronchial Asthma and Anti-inflammatory Drugs,"" The Journal of the Kuwaiti Medical Association, 22:165-167, 1988 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:33:42Z,,0,0,09000064805da217
FDA-1977-N-0025-0015,FDA,FDA-1977-N-0025,"Reference 84: Harman Fridrich, H., G. A. Zach, and K. L. Fridrich, ""Aspirin-Intolerance Syndrome: Report of a Case,"" Oral Surgery, Oral Medicine, and Oral Pathology, 61:463-465, 1986 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:43:30Z,,0,0,09000064805da21b
FDA-1977-N-0025-0082,FDA,FDA-1977-N-0025,"Reference 158: Milsom, I., and B. Andersch, ""Effect of Ibuprofen, Naproxen Sodium, and Paracetamol on Intrauterine Pressure and Menstrual Pain in Dysmenorrhea,"" British Journal of Obstetrics and Gynecology, 91:1129-1135, 1984 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:32:23Z,,0,0,09000064805da25b
FDA-1977-N-0025-0017,FDA,FDA-1977-N-0025,"Reference 86: Katz, J. et al., ""Drug Allergy in Sjogren's Syndrome,"" Lancet. 337:239, 1991 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T14:48:19Z,,0,0,09000064805da21d
FDA-1977-N-0025-0119,FDA,FDA-1977-N-0025,"Reference 144: Forbes, J. A. et al., ""Evaluation of Ketorolac, Ibuprofen, Acetaminophen, and an Acetaminophen-Codeine Combination in Post-Operative Oral Surgery Pain,"" Pharmacotherapy, 10 (Suppl. 6):94S-105S, 1990 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T19:52:52Z,,0,0,09000064805da28c
FDA-1977-N-0025-0090,FDA,FDA-1977-N-0025,"Reference 149: Mehlisch, D. R. et al., ""Multi-Center Clinical Trial of Ibuprofen and Acetaminophen in the Treatment of Postoperative Dental Pain,"" Journal of American Dental Association,121:257-263, 1990 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:08:20Z,,0,0,09000064805da253
FDA-1977-N-0025-0196,FDA,FDA-1977-N-0025,Request for Extension from Wyeth Consumer Healthcare,Other,Request for Extension,2018-01-02T05:00:00Z,2018,1,2018-01-02T05:00:00Z,2002-11-20T04:59:59Z,2019-02-01T16:52:28Z,,0,0,09000064805da2c7
FDA-1977-N-0025-0206,FDA,FDA-1977-N-0025,Reference List re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-01-31T20:28:50Z,,0,0,09000064805da2e5
FDA-1977-N-0025-0144,FDA,FDA-1977-N-0025,Background Material-CP13,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2018-01-02T19:17:49Z,,0,0,09000064805da29d
FDA-1977-N-0025-0170,FDA,FDA-1977-N-0025,"Reference 18: Cox, S. R., ""Effect of Route of Administration on the Chiral Inversion of R(-)-Ibuprofen"" (abstract). Clinical Pharmacology and Therapeutics. 43:146, 1988 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T13:29:56Z,,0,0,09000064805da2ad
FDA-1977-N-0025-0136,FDA,FDA-1977-N-0025,"Reference 40: Moore, N. et al., ""The PAIN Study: Paracetamol, Aspirin, and Ibuprofen, New Tolerability Study. A Large-Scale, Randomized Clinical Trial Comparing the Tolerability of Aspirin, Ibuprofen and Paracetamol for Short-Term Analgesia,"" Clinical Drug Investigations. 18:89-98, 1999 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-06T14:30:42Z,,0,0,09000064805da2a5
FDA-1977-N-0025-0061,FDA,FDA-1977-N-0025,"Reference 53: Furey, S. A., R. Vargas, and F. G. McMahan, ""Renovascular Effects of Nonprescription Ibuprofen in Elderly Hypertensive Patients with Mild Renal Impairment,"" Pharmacotherapy, 13:143-148, 1993 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 2 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T13:29:28Z,,0,0,09000064805da249
FDA-1977-N-0025-0086,FDA,FDA-1977-N-0025,"Reference 154: Schachtel, B. P., W. R. Thoden, and R. I. Baybutt, ""Ibuprofen and Acetaminophen in the Relief of Postpartum Episiotomy Pain,"" Journal of Clinical Pharmacology, 29:550-553, 1989 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:20:28Z,,0,0,09000064805da257
FDA-1977-N-0025-0201,FDA,FDA-1977-N-0025,Table of Contents re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-21T12:56:50Z,,0,0,09000064805da2dd
FDA-1977-N-0025-0223,FDA,FDA-1977-N-0025,Tab 5 re: Comment from Albemarle Corporation,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-22T14:20:49Z,,0,0,09000064805da2f6
FDA-1977-N-0025-0108,FDA,FDA-1977-N-0025,"Reference 109: Hoppmann, R. A., J. G. Peden, and S. K. Ober, ""Central Nervous System Side Effects of Nonsteroidal Anti-inflammatory Drugs,"" Archives of Internal Medicine, 151:1309-1313, 1991 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T17:23:07Z,,0,0,09000064805da26b
FDA-1977-N-0025-0068,FDA,FDA-1977-N-0025,"Reference 146: Forbes, J. A. et al., ""Analgesic Efficacy of Bromfenac, Ibuprofen, and Aspirin in Postoperative Oral Surgery Pain,"" Clinical Pharmacology, 51:343-352, 1992 re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 3 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-07T20:00:57Z,,0,0,09000064805da250
FDA-1977-N-0025-0150,FDA,FDA-1977-N-0025,"Reference 6: Summary Basis of Approval for New Drug Application for Ibuprofen (200 mg), OTC Vol. 03BTFM (1), Docket No. 77N-0941, Dockets Management Branch re: Background Material Public Administrative File OTC Volume 03BTFM (1) (Vol. 1 of 3)",Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-04T18:58:15Z,,0,0,09000064805da297
FDA-1977-N-0025-0208,FDA,FDA-1977-N-0025,3 NDAC Issues Raised re: Comment from McNeil Consumer & Specialty Pharmaceuticals,Supporting & Related Material,Background Material,2018-01-02T05:00:00Z,2018,1,,,2019-02-01T16:22:55Z,,0,0,09000064805da2e7