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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

154 rows where document_type = "Other" and posted_year = 2002 sorted by posted_date descending

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posted_year 1

  • 2002 · 154 ✖

document_type 1

  • Other · 154 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1992-V-0009-0001 FDA Laser Light Show - CLOSED FDA-1992-V-0009 Variance Approval from FDA CDRH to Jeff Cone Studios Other Approval for Variance (VRA) 2002-12-31T05:00:00Z 2002 12     2015-09-25T18:13:35Z   0 0 0900006480525e3b
FDA-2001-P-0214-0002 FDA Magnification Devices FDA-2001-P-0214 FDA/CDER to Veigh Hogan Other LET-Letter 2002-12-20T05:00:00Z 2002 12     2008-04-25T02:37:12Z   0 0 09000064804e474d
FDA-2002-P-0251-0003 FDA Determine if Phenergan has been withdrawn or withheld from s FDA-2002-P-0251 FDA/CDER to PharmaForce, Inc. Other LET-Letter 2002-12-20T05:00:00Z 2002 12     2008-04-12T01:27:49Z   0 0 090000648049bea0
FDA-2002-P-0077-0002 FDA Abbreviated new animal drug applicationIvermectin for cats-CLOSED FDA-2002-P-0077 FDA/CVM to Highland VetPharma, LLC. Other PAV-Petition Approval 2002-12-16T05:00:00Z 2002 12     2008-04-12T01:26:24Z   0 0 090000648048d32f
FDA-2002-P-0170-0002 FDA Suitability Petition for Ivermectin Soft-Chew Anthelmintic-CLOSED FDA-2002-P-0170 FDA/CVM to Intervet Inc. Other PAV-Petition Approval 2002-12-16T05:00:00Z 2002 12     2008-04-12T01:26:57Z   0 0 09000064804949b6
FDA-2002-P-0297-0002 FDA ANADA dosage form which differs for Ivermectin Equalan Paste-CLOSED FDA-2002-P-0297 FDA/CVM to Highland VetPharma, LLC Other PAV-Petition Approval 2002-12-16T05:00:00Z 2002 12     2008-04-12T01:28:08Z   0 0 090000648049f202
FDA-2002-P-0005-0002 FDA ANADA for ivermectin/pyrantel different dosage form-CLOSED FDA-2002-P-0005 FDA/CVM to Highland VetPharma, LLC Other PAV-Petition Approval 2002-12-16T05:00:00Z 2002 12     2008-04-12T01:25:47Z   0 0 0900006480487280
FDA-2002-P-0129-0003 FDA ANDAs Relaying Permax As Reference Listed Drug Not Be Approved-CLOSED FDA-2002-P-0129 FDA/CDER to Amarin Pharmaceuticals, Inc. Other PDN-Petition Denial 2002-12-06T05:00:00Z 2002 12     2008-04-12T01:26:43Z   0 0 09000064804905e5
FDA-2002-P-0259-0002 FDA Make determination of ANDA suitability for Amiodarone Hydroc-CLOSED FDA-2002-P-0259 FDA/CDER to Taro Research Institute Ltd. Other PAV-Petition Approval 2002-12-06T05:00:00Z 2002 12     2008-04-12T01:27:57Z   0 0 090000648049c57d
FDA-2002-P-0166-0002 FDA ANDA Suitability for Clozapine 50 mg Tablets-CLOSED FDA-2002-P-0166 FDA/CDER to AAC Consulting Group Other PAV-Petition Approval 2002-12-06T05:00:00Z 2002 12     2008-04-12T01:26:53Z   0 0 09000064804945df
FDA-2002-P-0173-0002 FDA ANDA for amoxicillin tabs for oral suspension 300 & 600mg-CLOSED FDA-2002-P-0173 FDA/CDER to The Weinberg Group Inc. Other PAV-Petition Approval 2002-12-06T05:00:00Z 2002 12     2008-04-12T01:27:00Z   0 0 0900006480494c28
FDA-1976-N-0027-0008 FDA OTC Nasal Decongestants FDA-1976-N-0027 Letter from FDA/CDER to Bayer Corporation Other Letter(s) 2002-11-27T05:00:00Z 2002 11     2015-10-29T19:49:11Z   0 0 090000648051b762
FDA-2002-P-0164-0002 FDA Refrain from Approving ANDA for Isotretinoin Drug Products - CLOSED FDA-2002-P-0164 FDA/CDER to Covington & Burling - Petition Approval Other PAV-Petition Approval 2002-11-15T05:00:00Z 2002 11     2012-07-11T22:03:47Z   0 0 090000648049444d
FDA-2002-P-0083-0002 FDA Physical form of drug product in to a oral liquid generic-CLOSED FDA-2002-P-0083 FDA/CVM to Phoenix Scientific, Inc. Other PAV-Petition Approval 2002-11-13T05:00:00Z 2002 11     2008-04-12T01:26:33Z   0 0 090000648048da81
FDA-2002-P-0215-0002 FDA ANADA for ivermectin having a different dosage form-CLOSED FDA-2002-P-0215 FDA/CDRH to Richdel, Inc. Other PAV-Petition Approval 2002-11-13T05:00:00Z 2002 11     2008-04-12T01:27:11Z   0 0 0900006480496a8f
FDA-2002-P-0254-0002 FDA ANADA for a generic version of trimethoprim & sulfadiazine c-CLOSED FDA-2002-P-0254 FDA/DDM to Pharmaceutical Solutions, Inc Other PAV-Petition Approval 2002-11-13T05:00:00Z 2002 11     2008-04-12T01:27:53Z   0 0 090000648049c210
FDA-1993-V-0063-0001 FDA Laser Light Show FDA-1993-V-0063 Laser Display Associates Inc. - Approval for Variance Other VRA-Approval for Variance 2002-11-08T05:00:00Z 2002 11     2008-11-06T13:39:02Z   0 0 09000064804fc98b
FDA-1993-V-0063-0002 FDA Laser Light Show FDA-1993-V-0063 Laser Display Associates Inc. - Approval for Variance Other VRA-Approval for Variance 2002-11-08T05:00:00Z 2002 11     2008-11-06T13:40:51Z   0 0 09000064804fc99b
FDA-1993-V-0063-0004 FDA Laser Light Show FDA-1993-V-0063 Laser Display Associates Inc. - Approval for Variance Other VRA-Approval for Variance 2002-11-08T05:00:00Z 2002 11     2008-11-06T13:44:05Z   0 0 09000064804fc99d
FDA-1993-V-0063-0003 FDA Laser Light Show FDA-1993-V-0063 Laser Display Associates Inc. - Approval for Variance Other VRA-Approval for Variance 2002-11-08T05:00:00Z 2002 11     2008-11-06T13:42:33Z   0 0 09000064804fc99c
FDA-2002-E-0525-0003 FDA Galileo Intravascular Radiotherapy System, US Patnet No. 5, 199,939 FDA-2002-E-0525 FDA/CDER to the USPTO - Letter Other LET-Letter 2002-11-05T05:00:00Z 2002 11     2008-07-17T19:38:07Z   0 0 09000064804a5765
FDA-2002-P-0226-0001 FDA Request for Rulemaking on Functional Foods & to Establish Advisory Committee FDA-2002-P-0226 FDA/CFSAN Interim Response to CSPI - Letter Other LET-Letter 2002-11-05T05:00:00Z 2002 11     2009-03-18T21:52:38Z   0 0 090000648049742e
FDA-2002-D-0309-0002 FDA Guidance Recommending Seizure & Destruction of Human/Animal FDA-2002-D-0309 Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been ReconditionedDraft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned Other Guidance 2002-11-04T05:00:00Z 2002 11 2020-09-28T04:00:00Z   2020-09-28T16:13:25Z   0 0 090000648049f977
FDA-2002-P-0258-0002 FDA ANDA for Levorphanol Tartrate Tablets-CLOSED FDA-2002-P-0258 FDA/CDER to Lachman Consultant Services, Other PAV-Petition Approval 2002-10-21T04:00:00Z 2002 10     2008-04-12T01:27:56Z   0 0 090000648049c4e7
FDA-2001-P-0193-0004 FDA ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg FDA-2001-P-0193 FDA/CDER to Mallinckrodt, Inc. Other LET-Letter 2002-10-21T04:00:00Z 2002 10     2008-04-25T02:27:24Z   0 0 09000064804e2af1
FDA-2002-P-0129-0002 FDA ANDAs Relaying Permax As Reference Listed Drug Not Be Approved-CLOSED FDA-2002-P-0129 FDA/CDER to Amarin Pharmaceuticals, Inc. Other LET-Letter 2002-10-16T04:00:00Z 2002 10     2008-04-12T01:26:43Z   0 0 09000064804905e4
FDA-2002-P-0211-0002 FDA Pharmacies of hospitals/other health care entities-CLOSED FDA-2002-P-0211 FDA to University of Colorado Hospit Other PAV-Petition Approval 2002-10-16T04:00:00Z 2002 10     2008-04-12T01:27:07Z   0 0 0900006480496792
FDA-2001-P-0191-0003 FDA Refrain Approval of Any Buprenorphine Product-CLOSED FDA-2001-P-0191 FDA/CDER to Hogan & Hartson, LLP Other PAV-Petition Approval 2002-10-16T04:00:00Z 2002 10     2008-04-25T02:25:58Z   0 0 09000064804e2727
FDA-2002-P-0213-0002 FDA The Labeling of Serono's REBIF is Misleading FDA-2002-P-0213 Letter from FDA CBER to Biogen, Inc. Other LET-Letter 2002-10-10T04:00:00Z 2002 10     2024-08-13T13:48:09Z   0 0 0900006480496906
FDA-2002-P-0133-0002 FDA Exemption of Any Connector In Lead Having A Conductive Connection-CLOSED FDA-2002-P-0133 FDA/CDRH to Hako-Med Other PDN-Petition Denial 2002-10-07T04:00:00Z 2002 10     2008-04-12T01:26:49Z   0 0 09000064804909eb
FDA-2001-D-0138-0003 FDA Exemptions from the Warning Label Requirement for Juice;Reco FDA-2001-D-0138 Exemptions from the Warning Label Requirement for Juice - Recommendations for Effectively Achieving a 5 -Log Pathogen Reduction Other Guidance 2002-10-04T04:00:00Z 2002 10 2020-09-28T04:00:00Z   2024-11-07T21:53:20Z   1 0 09000064804ddb44
FDA-2002-D-0189-0003 FDA Approval of Labeling for Foods Treated by Irradiation FDA-2002-D-0189 Guidance for Industry: Implementation of Section 10809 of the Farm Security and Investment Act of 2002 Regarding the Petition Process to Request Approval of Labeling for Foods that Have Been Treated with Irradiation Other Guidance 2002-10-04T04:00:00Z 2002 10 2020-09-28T04:00:00Z   2024-11-07T21:52:34Z   1 0 09000064804957e6
FDA-2000-P-1559-0002 FDA Action Against Manufacturers of Garlic Supplements Misbranded-CLOSED FDA-2000-P-1559 FDA/ORA to CSPI Other PDN-Petition Denial 2002-10-02T04:00:00Z 2002 10     2008-04-25T01:56:32Z   0 0 09000064804f9289
FDA-2002-P-0217-0002 FDA Carbidopa & Levodopa Orally Disintegrating Tablets-CLOSED FDA-2002-P-0217 HFD-600 to Lachman Consultant Services Other PAV-Petition Approval 2002-10-02T04:00:00Z 2002 10     2008-04-12T01:27:13Z   0 0 0900006480496ca3
FDA-2002-P-0127-0001 FDA Delcobese Tablets and Capsules FDA-2002-P-0127 FDA/DDM to Arent Fox Attorneys At Law Other ACK-Acknowledgement Letter 2002-10-01T04:00:00Z 2002 10     2008-04-12T01:26:40Z   0 0 0900006480490535
FDA-2002-P-0077-0001 FDA Abbreviated new animal drug applicationIvermectin for cats-CLOSED FDA-2002-P-0077 FDA/DDM to Highland VetPharma, LLC. Other ACK-Acknowledgement Letter 2002-09-30T04:00:00Z 2002 9     2008-04-12T01:26:24Z   0 0 090000648048d2ba
FDA-2002-P-0047-0003 FDA ANDA for Fenofibrate Tablets (Tricor) -CLOSED FDA-2002-P-0047 FDA/CDER to Lavender Consulting Services Other PAV-Petition Approval 2002-09-27T04:00:00Z 2002 9     2008-04-12T01:26:07Z   0 0 090000648048b830
FDA-2002-P-0050-0002 FDA Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5-CLOSED FDA-2002-P-0050 FDA/CDER to SciRegs Consulting Other PAV-Petition Approval 2002-09-27T04:00:00Z 2002 9     2008-04-12T01:26:10Z   0 0 090000648048b8a6
FDA-2002-P-0005-0001 FDA ANADA for ivermectin/pyrantel different dosage form-CLOSED FDA-2002-P-0005 FDA/DDM to Highland VetPharma, LLC Other ACK-Acknowledgement Letter 2002-09-26T04:00:00Z 2002 9     2008-04-12T01:25:47Z   0 0 0900006480487245
FDA-2002-P-0251-0002 FDA Determine if Phenergan has been withdrawn or withheld from s FDA-2002-P-0251 FDA/CDER to PharmaForce, Inc. Other LET-Letter 2002-09-19T04:00:00Z 2002 9     2008-04-12T01:27:49Z   0 0 090000648049be9d
FDA-2002-P-0297-0001 FDA ANADA dosage form which differs for Ivermectin Equalan Paste-CLOSED FDA-2002-P-0297 FDA/DDM to Highland VetPharma, LLC Other ACK-Acknowledgement Letter 2002-09-18T04:00:00Z 2002 9     2008-04-12T01:28:08Z   0 0 090000648049f1dd
FDA-1980-N-0074-0077 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 HFD-560 and Consumer Healthcare Prod Assn. Other MM-Memorandum of Meeting 2002-09-17T04:00:00Z 2002 9     2008-05-30T22:52:25Z   0 0 09000064805bb535
FDA-2002-P-0007-0001 FDA Cefuroxime Axetil Tablets Oral suspension 125mg & 250mg ANDA - CLOSED FDA-2002-P-0007 Acknowledgement Letter from FDA DMB to the Weinberg Group Inc. Other Acknowledgement Letter/Receipt 2002-09-16T04:00:00Z 2002 9     2024-09-06T14:52:47Z   0 0 0900006480487409
FDA-2001-P-0119-0003 FDA Issue the NFR Placement of Anthrax Vaccine as Category II-CLOSED FDA-2001-P-0119 HF-11 to Russell E Dingle Other PAV-Petition Approval 2002-09-11T04:00:00Z 2002 9     2008-04-25T02:25:02Z   0 0 09000064804bc584
FDA-2001-P-0119-0004 FDA Issue the NFR Placement of Anthrax Vaccine as Category II-CLOSED FDA-2001-P-0119 HF-11 to Russell E Dingle Other PAV-Petition Approval 2002-09-11T04:00:00Z 2002 9     2008-04-25T02:25:02Z   0 0 09000064804bc587
FDA-2001-P-0119-0001 FDA Issue the NFR Placement of Anthrax Vaccine as Category II-CLOSED FDA-2001-P-0119 HF-11 to Russell E Dingle Other PAV-Petition Approval 2002-09-11T04:00:00Z 2002 9     2008-04-25T02:25:02Z   0 0 09000064804bc111
FDA-2001-P-0119-0002 FDA Issue the NFR Placement of Anthrax Vaccine as Category II-CLOSED FDA-2001-P-0119 HF-11 to Russell E Dingle Other PAV-Petition Approval 2002-09-11T04:00:00Z 2002 9     2008-04-25T02:25:04Z   0 0 09000064804bc581
FDA-2002-P-0170-0001 FDA Suitability Petition for Ivermectin Soft-Chew Anthelmintic-CLOSED FDA-2002-P-0170 FDA/DDM to Intervet Inc. Other ACK-Acknowledgement Letter 2002-09-05T04:00:00Z 2002 9     2008-04-12T01:26:57Z   0 0 0900006480494967
FDA-2002-P-0043-0001 FDA Determine Whether Niaspan Tablets, NDA 020381 Have Been FDA-2002-P-0043 FDA/DDM to Barr Laboratories Other ACK-Acknowledgement Letter 2002-09-05T04:00:00Z 2002 9     2008-04-12T01:26:03Z   0 0 090000648048b7b4
FDA-2002-P-0069-0001 FDA Determine Whether Estrostep 21 Tablets, NDA 020130 Have Been FDA-2002-P-0069 Acknowledgment Letter from FDA/DMB to Barr Laboratories, Inc. Other Acknowledgement Letter/Receipt 2002-09-05T04:00:00Z 2002 9     2024-09-06T14:52:11Z   0 0 090000648048c9f2
FDA-2002-P-0042-0001 FDA Determine Whether Ortho-Tri-Cyclen-21 has been Voluntarily FDA-2002-P-0042 FDA/DDM to Barr Laboratories, Inc. Other ACK-Acknowledgement Letter 2002-09-04T04:00:00Z 2002 9     2008-04-12T01:26:02Z   0 0 090000648048b78e
FDA-2002-P-0259-0001 FDA Make determination of ANDA suitability for Amiodarone Hydroc-CLOSED FDA-2002-P-0259 FDA/DDM to Taro Research Institute Ltd. Other ACK-Acknowledgement Letter 2002-09-04T04:00:00Z 2002 9     2008-04-12T01:27:57Z   0 0 090000648049c53a
FDA-2002-P-0206-0001 FDA Determine whether Ortho-Cyclen-21 Tablets,NDA 19 652 have FDA-2002-P-0206 FDA/DDM to Barr Laboratories, Inc Other ACK-Acknowledgement Letter 2002-09-04T04:00:00Z 2002 9     2008-04-12T01:27:01Z   0 0 09000064804961e6
FDA-2001-M-0146-0002 FDA P000035;TMJ Fossa-Eminence Prosthesis FDA-2001-M-0146 Petition Denial letter from FDA/CDRH to The TMJ Association Other Denial of Petition 2002-08-20T04:00:00Z 2002 8     2025-03-06T14:54:59Z   0 0 09000064804ddc65
FDA-2002-P-0006-0002 FDA ANDA Suitability for Isotretinoin Capsules 30 mg-CLOSED FDA-2002-P-0006 FDA/CDER to Lachman Consultant Services, Other PAV-Petition Approval 2002-08-12T04:00:00Z 2002 8     2008-04-12T01:25:47Z   0 0 0900006480487367
FDA-2002-P-0049-0002 FDA ANDA Suitability for Oxycodone and Acetaminophen Tablets-CLOSED FDA-2002-P-0049 HFD-600 to Lachman Consultant Services, Other PAV-Petition Approval 2002-08-12T04:00:00Z 2002 8     2008-04-12T01:26:09Z   0 0 090000648048b86b
FDA-2002-P-0293-0001 FDA Chemical Cleaning Products for Industrial Food FDA-2002-P-0293 FDA/DDM to J. B. Proveedores S.A. DE C. Other ACK-Acknowledgement Letter 2002-08-12T04:00:00Z 2002 8     2008-04-12T01:28:04Z   0 0 090000648049f011
FDA-1977-N-0002-0945 FDA Penicillin & Tetracycline & All Combinations - CLOSED FDA-1977-N-0002 Letter from Gordon Tate re: Comment from The National Grange Other Letter(s) 2002-08-09T04:00:00Z 2002 8     2019-05-09T15:43:48Z   0 0 09000064805d702a
FDA-2002-P-0173-0001 FDA ANDA for amoxicillin tabs for oral suspension 300 & 600mg-CLOSED FDA-2002-P-0173 FDA/DDM to The Weinberg Group Inc. Other ACK-Acknowledgement Letter 2002-08-09T04:00:00Z 2002 8     2008-04-12T01:27:00Z   0 0 0900006480494bf2
FDA-2002-P-0295-0002 FDA SRNT petition to regulate SF Garrett's Nicotine Water FDA-2002-P-0295 FDA/OC to Society Res Nicotine and Tobacc Other LET-Letter 2002-08-08T04:00:00Z 2002 8     2008-04-12T01:28:06Z   0 0 090000648049f159
FDA-2001-P-0189-0002 FDA ANDA filed for Midazolam Injection (Preservative Free)-CLOSED FDA-2001-P-0189 FDA/CDER to Abbott Laboratories Other PAV-Petition Approval 2002-08-08T04:00:00Z 2002 8     2008-04-25T02:27:15Z   0 0 09000064804e2459
FDA-2020-D-1952-0001 FDA FDA-2020-D-1952 CPG Sec. 315.200 Status of Dental Supplies Such as Denture Cleaners Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG REVOKED effective 8/07/2002) Other Guidance 2002-08-06T04:00:00Z 2002 8 2020-09-21T04:00:00Z   2024-11-12T23:24:58Z   1 0 0900006484868fc6
FDA-2001-P-0155-0004 FDA Requirement of ANDA for Mixed Salts of Single Entity Amphetamine-CLOSED FDA-2001-P-0155 FDA/CDER to Arnall Golden Gregory, LLP Other PDN-Petition Denial 2002-08-05T04:00:00Z 2002 8     2008-04-25T02:27:48Z   0 0 09000064804df154
FDA-1978-N-0018-0450 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Acknowledgment Letter from FDA/DDM to Procter & Gamble Company Other Acknowledgement Letter/Receipt 2002-07-26T04:00:00Z 2002 7     2019-08-06T13:26:48Z   0 0 090000648055a84c
FDA-1978-N-0018-0451 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Acknowledgment Letter from FDA/DDM to The Cosmetic, Toiletry & Fragrance Association and The Consumer Healthcare Products Association Other Acknowledgement Letter/Receipt 2002-07-26T04:00:00Z 2002 7     2019-07-26T15:13:22Z   0 0 090000648055a84e
FDA-1996-N-0006-0013 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER to Ciba Specialty Chemicals Other Letter(s) 2002-07-17T04:00:00Z 2002 7     2015-03-19T18:07:53Z   0 0 09000064804f9976
FDA-2002-P-0247-0001 FDA Recall Aspartame as a Neurotoxic Drug-Closed FDA-2002-P-0247 Acknowledgement Letter to Mission Possible International Other ACK-Acknowledgement Letter 2002-07-16T04:00:00Z 2002 7     2009-03-30T14:23:20Z   0 0 090000648049abb8
FDA-2002-P-0247-0002 FDA Recall Aspartame as a Neurotoxic Drug-Closed FDA-2002-P-0247 Acknowledgement Letter to Mission Possible International Other ACK-Acknowledgement Letter 2002-07-16T04:00:00Z 2002 7     2009-03-24T12:05:11Z   0 0 090000648049ac7e
FDA-2001-P-0056-0004 FDA Hydrocodone Bitartrate and Acetaminophen Products-CLOSED FDA-2001-P-0056 FDA/CDER to Pharmaceutical Associates, Inc. Other PDN-Petition Denial 2002-07-12T04:00:00Z 2002 7     2008-04-25T01:57:35Z   0 0 09000064804b7ec9
FDA-1999-P-0126-0007 FDA Abbreviated new drug application/topical dematological drug-CLOSED FDA-1999-P-0126 FDA/CDER to GlaxoSmithKline Other PAV-Petition Approval 2002-07-12T04:00:00Z 2002 7     2008-04-25T00:19:51Z   0 0 09000064804ae9f3
FDA-1999-P-0126-0008 FDA Abbreviated new drug application/topical dematological drug-CLOSED FDA-1999-P-0126 FDA/CDER to Pharmacia & Upjohn Other PAV-Petition Approval 2002-07-12T04:00:00Z 2002 7     2008-04-25T00:19:51Z   0 0 09000064804ae9f5
FDA-2000-P-0153-0002 FDA ANDA Suitability Petition for Ursodiol Oral Suspension-CLOSED FDA-2000-P-0153 FDA/CDER to Lachman Consultant Services, Inc. Other PDN-Petition Denial 2002-07-12T04:00:00Z 2002 7     2008-04-25T01:45:52Z   0 0 09000064804d1424
FDA-2001-P-0055-0002 FDA ANDA Suitability for Topical Cream Containing 5% Lidocaine-CLOSED FDA-2001-P-0055 FDA/CDER to Ferndale Laboratories, Inc. Other PDN-Petition Denial 2002-07-10T04:00:00Z 2002 7     2008-04-25T01:57:35Z   0 0 09000064804b7ea1
FDA-2001-P-0088-0002 FDA ANDA for Pentoxifylline Extended-release Tablets, 500 mg.-CLOSED FDA-2001-P-0088 FDA/CDER to The Weinberg Group Inc. Other PDN-Petition Denial 2002-07-10T04:00:00Z 2002 7     2008-04-25T02:24:43Z   0 0 09000064804b866e
FDA-2001-P-0030-0003 FDA Prescription Drug Products List Amendment & Approve New Dosage-CLOSED FDA-2001-P-0030 FDACDER Response to Duramed Pharmaceuticals, Inc. - Petition Approval Other PAV-Petition Approval 2002-07-10T04:00:00Z 2002 7     2013-07-27T21:00:02Z   0 0 09000064804b609d
FDA-2000-P-0214-0002 FDA ANDA for Sertraline Hydrochloride Capsules 25mg, 50mg & 100m-CLOSED FDA-2000-P-0214 FDA/CDER to Lachman Consultant Services, Other PAV-Petition Approval 2002-07-10T04:00:00Z 2002 7     2008-04-25T01:14:22Z   0 0 09000064804d4e71
FDA-2002-P-0070-0003 FDA Determine Pipracil Was Withdrawn For Safety Reasons FDA-2002-P-0070 FDA/DDM to Michael Lisjak Other LET-Letter 2002-07-08T04:00:00Z 2002 7     2008-04-12T01:26:13Z   0 0 090000648048cb0b
FDA-2002-P-0003-0003 FDA Seek immediate final approval of generic tramadol hydrochloride-CLOSED FDA-2002-P-0003 FDA/DDM to Johnson & Johnson Other ACK-Acknowledgement Letter 2002-07-02T04:00:00Z 2002 7     2008-04-12T01:25:45Z   0 0 09000064804870bf
FDA-2002-P-0291-0004 FDA Request for immediate final approval of tramadol Hydrochlori-CLOSED FDA-2002-P-0291 FDA/DDM to Ortho-McNeil Other ACK-Acknowledgement Letter 2002-07-02T04:00:00Z 2002 7     2008-04-12T01:28:02Z   0 0 090000648049eeef
FDA-1996-N-0006-0005 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Response Letter from FDA/CDER to Buchanan Ingersoll Professional Corporation Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-03-19T18:40:20Z   0 0 09000064804f9969
FDA-1996-N-0006-0010 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER to Ciba Specialty Chemicals Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-03-20T13:54:01Z   0 0 09000064804f9973
FDA-1996-N-0006-0009 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER to Rural Industries Research & Development Corporation Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-06-19T20:38:35Z   0 0 09000064804f9972
FDA-1996-N-0006-0007 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Response from FDA/CDER to Bass & Ullman, P.C. Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-06-19T20:38:06Z   0 0 09000064804f996e
FDA-1996-N-0006-0006 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Response from FDA/CDER to BASF AG [Morgan, Lewis & Bockius, LLP] Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-03-19T20:19:26Z   0 0 09000064804f996d
FDA-1996-N-0006-0011 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER to EM Industries, Inc. Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-03-19T17:39:10Z   0 0 09000064804f9974
FDA-1996-N-0006-0008 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Response from FDA/CDER to The Procter & Gamble Company Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-03-19T20:35:10Z   0 0 09000064804f9971
FDA-1996-N-0006-0012 FDA Eligibility Criteria for Considering Additional Conditions in the Over-the-Counter Drug Monograph System FDA-1996-N-0006 Letter from FDA/CDER to Covington & Burling Other Letter(s) 2002-06-26T04:00:00Z 2002 6     2015-06-19T20:40:35Z   0 0 09000064804f9975
FDA-2002-P-0219-0001 FDA Combination Oxycodone Hydrochloride/Acetaminophen Tablet-CLOSED FDA-2002-P-0219 FDA/DDM to King & Spalding Other ACK-Acknowledgement Letter 2002-06-25T04:00:00Z 2002 6     2008-04-12T01:27:15Z   0 0 0900006480496e1a
FDA-2020-D-1953-0001 FDA FDA-2020-D-1953 CPG Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps - revoked 6/20/02 Other Guidance 2002-06-20T04:00:00Z 2002 6 2020-09-21T04:00:00Z   2024-11-06T23:39:05Z   1 0 0900006484868fc8
FDA-2002-P-0050-0001 FDA Suitability Petition for Hydrocodone Bitartrate/Ibuprofen 5-CLOSED FDA-2002-P-0050 FDA/DDM to SciRegs Other ACK-Acknowledgement Letter 2002-06-13T04:00:00Z 2002 6     2008-04-12T01:26:10Z   0 0 090000648048b8a2
FDA-2001-P-0191-0002 FDA Refrain Approval of Any Buprenorphine Product-CLOSED FDA-2001-P-0191 FDA/CDER to Hogan & Hartson, LLP Other LET-Letter 2002-06-12T04:00:00Z 2002 6     2008-04-25T02:25:58Z   0 0 09000064804e2721
FDA-2002-P-0291-0003 FDA Request for immediate final approval of tramadol Hydrochlori-CLOSED FDA-2002-P-0291 FDA/CDER to Teva Pharmaceuticals USA, Inc. Other PAV-Petition Approval 2002-06-12T04:00:00Z 2002 6     2008-04-12T01:28:02Z   0 0 090000648049eee9
FDA-2002-P-0003-0002 FDA Seek immediate final approval of generic tramadol hydrochloride-CLOSED FDA-2002-P-0003 FDA/CDER to Caraco Pharms Labs, Ltd. Other PAV-Petition Approval 2002-06-12T04:00:00Z 2002 6     2008-04-12T01:25:45Z   0 0 09000064804870b7
FDA-2000-P-0151-0003 FDA Amend definition & standard of identity for parmesan cheese-CLOSED FDA-2000-P-0151 FDA/CFSAN & Sartori Food Corp. Other MT-Memorandum of Telephone Conversation 2002-06-11T04:00:00Z 2002 6     2008-04-25T01:31:51Z   0 0 09000064804d1180
FDA-2002-P-0211-0001 FDA Pharmacies of hospitals/other health care entities-CLOSED FDA-2002-P-0211 FDA/DDM to University of Colorado Hospital Other ACK-Acknowledgement Letter 2002-06-04T04:00:00Z 2002 6     2008-04-12T01:27:07Z   0 0 0900006480496755
FDA-1980-N-0036-0012 FDA Antifungal Drug Products for O. T. C. Human Use FDA-1980-N-0036 FDA/Office of the Commissioner to The Purdue Fredrick Company Other LET-Letter 2002-05-31T04:00:00Z 2002 5     2008-12-05T14:27:46Z   0 0 09000064805b948c
FDA-2002-P-0003-0001 FDA Seek immediate final approval of generic tramadol hydrochloride-CLOSED FDA-2002-P-0003 FDA/DDM to Winston & Strawn Other ACK-Acknowledgement Letter 2002-05-31T04:00:00Z 2002 5     2008-04-12T01:25:45Z   0 0 090000648048707d
FDA-2002-P-0166-0001 FDA ANDA Suitability for Clozapine 50 mg Tablets-CLOSED FDA-2002-P-0166 FDA/DDM to AAC Consulting Group Other ACK-Acknowledgement Letter 2002-05-30T04:00:00Z 2002 5     2008-04-12T01:26:53Z   0 0 09000064804945ae
FDA-1995-P-0044-0002 FDA Modify Advice Bioequivalence of generic ammonium lactate-CLOSED FDA-1995-P-0044 FDA/CDER to Westwood Squibb Pharms, Inc. Other CR-Correction 2002-05-24T04:00:00Z 2002 5     2008-05-16T23:07:31Z   0 0 090000648056143c
FDA-2001-P-0216-0003 FDA To Remove False and Deceptive Labeling for Transderm Scope-CLOSED FDA-2001-P-0216 FDA/CDER to Pharmacia Consumer Healthcare I Other PAV-Petition Approval 2002-05-16T04:00:00Z 2002 5     2008-04-25T02:38:56Z   0 0 09000064804e4a2a

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
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);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);