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

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1,542 rows where agency_id = "FDA", document_type = "Other" and posted_year = 2004 sorted by posted_date descending

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  • 2004 · 1,542 ✖

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  • Other · 1,542 ✖

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  • FDA · 1,542 ✖
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2004-N-0318-0006 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:48:39Z   0 0 090000648047300c
FDA-2004-N-0318-0003 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:25Z   0 0 0900006480473009
FDA-2004-N-0318-0004 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:41Z   0 0 090000648047300a
FDA-2004-P-0401-0001 FDA Request the Commissioner of Food and Drugs re-evaluate FDA's policy concerning the marketing of 'authorized generic' versions of brand name prescription drugs. - CLOSED FDA-2004-P-0401 Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2004-12-29T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-28T01:00:45Z   0 0 09000064804744d0
FDA-2004-P-0401-0002 FDA Request the Commissioner of Food and Drugs re-evaluate FDA's policy concerning the marketing of 'authorized generic' versions of brand name prescription drugs. - CLOSED FDA-2004-P-0401 Acknowledgment Letter from FDA/CDER to Andrx Pharmaceuticals, Inc. Other Acknowledgement Letter/Receipt 2004-12-29T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T21:26:48Z   0 0 09000064804744d6
FDA-2004-N-0318-0002 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:47:08Z   0 0 0900006480473008
FDA-2004-N-0318-0005 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Transcript of November 18, 2004 Stakeholder Meeting Other Transcript(s) 2004-12-29T05:00:00Z 2004 12     2025-09-26T17:48:17Z   0 0 090000648047300b
FDA-2004-N-0318-0011 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 MDUFMA and the GMP Inspection Program Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:56:03Z   0 0 0900006480473015
FDA-2004-N-0318-0012 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 BIMO and MDUFMA Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:59:49Z   0 0 0900006480473016
FDA-2004-N-0318-0015 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Inspection by Accredited persons (AP) Program Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:15:34Z   0 0 0900006480473019
FDA-2004-N-0318-0014 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 CBER and MDUFMA Quantitative Goals Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:11:01Z   0 0 0900006480473018
FDA-2004-N-0318-0009 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Premarket Review Performance Goals Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:51:39Z   0 0 0900006480473011
FDA-2004-N-0318-0013 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Modular PMA Updates Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:07:48Z   0 0 0900006480473017
FDA-2004-N-0318-0007 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Agenda for November 18, 2004 Meeting Other List (LST) 2004-12-29T00:00:00Z 2004 12     2025-04-30T16:39:05Z   0 0 090000648047300d
FDA-2004-N-0318-0010 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 CBER MDUFMA Activity Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:52:55Z   0 0 0900006480473012
FDA-2004-N-0318-0016 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Reuse of Single Use Devices Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T17:18:33Z   0 0 090000648047301b
FDA-2004-N-0318-0008 FDA Second Annual Stakeholder Meeting on the Implementation of the Medical Device User Fee and Modernization Act of 2002 Provisions; Public Meeting FDA-2004-N-0318 Financial Aspects of MDUFMA Other Testimony 2004-12-29T00:00:00Z 2004 12     2025-04-30T18:50:19Z   0 0 090000648047300e
FDA-1980-N-0049-0088 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:41:00Z   0 0 09000064805b99f4
FDA-1980-N-0049-0091 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:51:32Z   0 0 09000064805b99f7
FDA-1980-N-0049-0089 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:44:51Z   0 0 09000064805b99f5
FDA-2004-P-0345-0002 FDA ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg-CLOSED FDA-2004-P-0345 Acknowledgment Letter from FDA DMB to Lachman Consultant Services, Inc. Other ACK-Acknowledgement Letter 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T20:51:13Z   0 0 09000064804734a7
FDA-2004-P-0096-0002 FDA ANDA Suitability for Acetaminophen, Butalbital Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg-CLOSED FDA-2004-P-0096 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T19:34:05Z   0 0 090000648046f4ed
FDA-2004-P-0363-0001 FDA Request Immediate Recall of All Unapproved Methacholine Chloride Products-CLOSED FDA-2004-P-0363 Acknowledgment Letter from FDA/DMB to Methapharm, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T21:01:11Z   0 0 090000648047364f
FDA-1980-N-0049-0087 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:27:53Z   0 0 09000064805b99f3
FDA-1980-N-0049-0092 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:56:57Z   0 0 09000064805b99f8
FDA-1980-N-0049-0090 FDA Biological Products; Bacterial Vaccines & Toxiods FDA-1980-N-0049 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review Other Report 2004-12-27T05:00:00Z 2004 12     2020-05-21T12:47:47Z   0 0 09000064805b99f6
FDA-2004-P-0345-0001 FDA ANDA Suitability for Acetaminophen, Butalbital and Caffeine Capsules USP, 300 mg/50 mg/40 mg-CLOSED FDA-2004-P-0345 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T20:38:11Z   0 0 09000064804734a2
FDA-2004-P-0096-0001 FDA ANDA Suitability for Acetaminophen, Butalbital Caffeine and Codeine Phosphate Capsules, 300 mg/50 mg/40 mg/30 mg-CLOSED FDA-2004-P-0096 Acknowledgment Letter from FDA/DMB to Lachman Consultant Services, Inc. Other Acknowledgement Letter/Receipt 2004-12-27T05:00:00Z 2004 12 2004-12-27T05:00:00Z   2025-03-27T19:29:18Z   0 0 090000648046f4e6
FDA-2004-D-0122-0002 FDA Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Availability FDA-2004-D-0122 Compliance Guidance for Small Business Entities on Labeling Over-the-Counter Human Drug Products; Draft Guidance Other GDL-Guidance (Supporting and Related Materials) 2004-12-23T05:00:00Z 2004 12     2013-08-11T04:06:32Z   0 0 090000648046fbbe
FDA-2004-P-0338-0001 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732f6
FDA-2004-P-0338-0002 FDA Refrain From Approving Any ANDA Submitted Under Section 505(j) of the FDCA for A Generic Version of Efudex Cream-CLOSED FDA-2004-P-0338 HFA-305 to Valeant Pharmaceuticals International Other ACK-Acknowledgement Letter 2004-12-22T05:00:00Z 2004 12     2008-04-12T00:49:25Z   0 0 09000064804732ff
FDA-2004-S-0442-0003 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Agenda for November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:54Z   0 0 0900006480474a96
FDA-2004-V-0030-0002 FDA Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems FDA-2004-V-0030 HFA-305 to Varian Medical Systems Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:58Z   0 0 090000648046a954
FDA-2004-S-0442-0006 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Attendees to November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:54Z   0 0 0900006480474a99
FDA-2004-V-0362-0002 FDA Laser Light Show regarding Mobolazer RG-50 Beam FDA-2004-V-0362 HFA-305 to G and G Sound and Lighting Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:53:37Z   0 0 0900006480473647
FDA-2004-S-0442-0004 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Agenda for November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:55Z   0 0 0900006480474a97
FDA-2004-V-0030-0001 FDA Acuity, K033339 and On Board Imaging, K042720 Optional Therapy Simulation Systems FDA-2004-V-0030 HFA-305 to Varian Medical Systems Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:58Z   0 0 090000648046a950
FDA-2004-S-0442-0007 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Transcript the November 8, 2004 meeting Other TR-Transcript 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:54Z   0 0 0900006480474a9a
FDA-2004-P-0472-0003 FDA Designate An Official Name for Cis-8-Methyl-N-Vanillyl-6-Nonenamide Different than Zucapsaicin-CLOSED FDA-2004-P-0472 HFD-005 to Winston Laboratories, Inc. Other LET-Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:50:23Z   0 0 0900006480475c8d
FDA-2004-S-0442-0005 FDA Solicitation of Comments on Stimulating Innovation in Medical Technologies FDA-2004-S-0442 Agenda for November 8, 2004 meeting Other LST-List 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:52:55Z   0 0 0900006480474a98
FDA-2004-V-0362-0001 FDA Laser Light Show regarding Mobolazer RG-50 Beam FDA-2004-V-0362 HFA-305 to G and G Sound and Lighting Other ACK-Acknowledgement Letter 2004-12-21T05:00:00Z 2004 12     2008-04-12T00:53:37Z   0 0 0900006480473643
FDA-2003-H-0215-0044 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 HFA-305 Other CS-Certificate of Service 2004-12-17T05:00:00Z 2004 12     2008-04-12T00:57:12Z   0 0 090000648048c767
FDA-2000-N-0109-0127 FDA Enrofloxacin for Poultry: Opportunity for Hearing FDA-2000-N-0109 Exhibit B-294: Reserved Other Exhibit(s) 2004-12-16T05:00:00Z 2004 12     2026-02-17T19:24:19Z   0 0 09000064804cd9b1
FDA-2003-H-0215-0040 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 HF-3 Other OR-Order 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:57:11Z   0 0 090000648048c75e
FDA-2004-V-0032-0001 FDA Projector for a Laser Light Show FDA-2004-V-0032 HFA-305 to Mezzanotte LLC Other ACK-Acknowledgement Letter 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:52:59Z   0 0 090000648046a963
FDA-2003-H-0215-0041 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 HFA-305 to Henry E. Schwartz LLC Other CS-Certificate of Service 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:57:13Z   0 0 090000648048c760
FDA-2004-V-0031-0001 FDA Laser Light Show FDA-2004-V-0031 HFA-305 t0 Tinsletown 17 Other ACK-Acknowledgement Letter 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:52:59Z   0 0 090000648046a95b
FDA-2004-P-0176-0001 FDA Determine that AstraZeneca LP's Xylocaine (lidocaine) 10% Oral Spray (NDA 14-394) was voluntarily withdrawn or withheld from sale for reasons other than safety or effficacy - CLOSED FDA-2004-P-0176 Acknowledgement Letter from FDA/DMB to Arent Fox Other Acknowledgement Letter/Receipt 2004-12-15T05:00:00Z 2004 12 2004-12-15T05:00:00Z   2025-03-26T21:57:46Z   0 0 09000064804701a9
FDA-2003-H-0215-0039 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 GCF-1 Other RMO-Reply to Motion 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:57:12Z   0 0 090000648048c75b
FDA-2004-V-0238-0003 FDA Projector for a Laser Light Show FDA-2004-V-0238 HFZ-300 to Jake Barner Studios Other VRA-Approval for Variance 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:53:25Z   0 0 09000064804718d2
FDA-2004-V-0296-0004 FDA Laser Light Show LUMALASER Beamburst Emerald 50 FDA-2004-V-0296 HFA-300 to Hot Wax Unlimited Other VRA-Approval for Variance 2004-12-15T05:00:00Z 2004 12     2008-04-12T00:53:30Z   0 0 0900006480472d00
FDA-2004-P-0018-0002 FDA Take Immediate Action to Cease the Unlawful Distribution of Misbranded, Adulterated & Unlabeled Cosmetics-CLOSED FDA-2004-P-0018 Letter from FDA CFSAN to Environmental Working Group Other Letter(s) 2004-12-15T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-02-11T21:39:27Z   0 0 090000648046a8b2
FDA-2004-P-0018-0001 FDA Take Immediate Action to Cease the Unlawful Distribution of Misbranded, Adulterated & Unlabeled Cosmetics-CLOSED FDA-2004-P-0018 Letter from FDA CFSAN to Environmental Working Group Other Letter(s) 2004-12-15T05:00:00Z 2004 12 2004-12-14T05:00:00Z   2025-02-12T02:00:43Z   0 0 090000648046a8a6
FDA-1993-V-0011-0001 FDA Laser Light Show FDA-1993-V-0011 Kozmic Lazer Show, LLP - Approval for Variance Other VRA-Approval for Variance 2004-12-13T05:00:00Z 2004 12     2008-11-06T14:53:19Z   0 0 09000064804fa256
FDA-2004-P-0474-0003 FDA Withdraw the approval of ANDA suitability petition that is not incompliance with the Pediatric Research Equity Act of 2003 and does not satisfy other criteria for approval of an ANDA suitability petition-CLOSED FDA-2004-P-0474 FDA/CDER to King & Spalding LLP Other LET-Letter 2004-12-13T05:00:00Z 2004 12     2008-04-12T00:50:25Z   0 0 0900006480475ce2
FDA-2004-P-0418-0002 FDA ANDA for Drug Product that Differs Form the Reference Listed Drug In Strength for Ondansetron Hydrochloride Injection, 8mg/4mL Prefiled syringes - CLOSED FDA-2004-P-0418 Acknowledgment Letter from FDA/DMB to Olsson, Frank and Weeda, P.C. Other Acknowledgement Letter/Receipt 2004-12-10T05:00:00Z 2004 12 2004-12-10T05:00:00Z   2025-03-26T21:05:28Z   0 0 0900006480474614
FDA-2004-P-0418-0001 FDA ANDA for Drug Product that Differs Form the Reference Listed Drug In Strength for Ondansetron Hydrochloride Injection, 8mg/4mL Prefiled syringes - CLOSED FDA-2004-P-0418 Acknowledgment Letter from FDA/DMB to Olsson, Frank and Weeda, P.C. Other Acknowledgement Letter/Receipt 2004-12-10T05:00:00Z 2004 12 2004-12-10T05:00:00Z   2025-03-26T21:03:10Z   0 0 090000648047460e
FDA-2004-P-0343-0003 FDA Nutrient Content Claims fo Carbohydrates in Food Labeling FDA-2004-P-0343 Acknowledgment Letter from FDA/DMB to MGP Ingredients, Inc. Other Acknowledgement Letter/Receipt 2004-12-09T05:00:00Z 2004 12 2004-12-09T05:00:00Z   2025-03-26T20:46:32Z   0 0 090000648047346a
FDA-2003-H-0215-0038 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 HFA-305 to Henry E. Schwartz LLC Other CS-Certificate of Service 2004-12-09T05:00:00Z 2004 12     2008-04-12T00:57:13Z   0 0 090000648048c759
FDA-2004-P-0343-0002 FDA Nutrient Content Claims fo Carbohydrates in Food Labeling FDA-2004-P-0343 Acknowledgment Letter from FDA/DMB to MGP Ingredients, Inc. Other Acknowledgement Letter/Receipt 2004-12-09T05:00:00Z 2004 12 2004-12-09T05:00:00Z   2025-03-26T20:44:55Z   0 0 0900006480473468
FDA-2003-H-0215-0037 FDA Civil Money Penalty, Korangy Radiology Associates, PA dba Baltimore Imaging Centers, Amile A Korangy, MD FDA-2003-H-0215 HF-3 Other OR-Order 2004-12-09T05:00:00Z 2004 12     2008-04-12T00:57:12Z   0 0 090000648048c757
FDA-2004-P-0343-0001 FDA Nutrient Content Claims fo Carbohydrates in Food Labeling FDA-2004-P-0343 Acknowledgment Letter from FDA/DMB to MGP Ingredients, Inc. Other Acknowledgement Letter/Receipt 2004-12-09T05:00:00Z 2004 12 2004-12-09T05:00:00Z   2025-03-26T20:42:22Z   0 0 0900006480473464
FDA-2004-P-0282-0002 FDA Declare that Glipizide and Metformin Hydrochloride Oral Solution, 2.5 mg/250 mg per 5 mL; 2.5 mg/500 mg per 10 mL and 5 mg/500 mg per 10 mL is suitable for submission as an ANDA-CLOSED FDA-2004-P-0282 Citizen Petition Approval from FDA CDER to Lachman Consultant Services, Inc. Other Approval 2004-12-08T05:00:00Z 2004 12 2004-11-23T05:00:00Z   2025-01-07T22:58:45Z   0 0 09000064804726dd
FDA-2001-P-0003-0002 FDA Request that '365 Patent Not be Re-listed in Orange Book FDA-2001-P-0003 HFD-7 to Rothwell, Figg, Ernst & Manbeck, PC (Mylan Pharmaceuticals Inc) Other CR-Correction 2004-12-08T05:00:00Z 2004 12     2024-09-10T19:33:13Z   0 0 09000064804b3dc7
FDA-2004-N-0569-0014 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 List of participants, attendees Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:45:32Z   0 0 090000648048332b
FDA-2004-N-0569-0006 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Transcript of November 15, 2004 Public Meeting Other TR-Transcript 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:45:55Z   0 0 090000648048330b
FDA-2004-N-0569-0012 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Director, Division of Dietary Supplement Programs, FDA Other TS-Testimony 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:44:31Z   0 0 0900006480483311
FDA-2004-N-0569-0011 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Director, Division of Dietary Supplement Programs, FDA Other TS-Testimony 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:46:18Z   0 0 0900006480483310
FDA-2004-N-0569-0015 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 List of participants, attendees Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:45:32Z   0 0 090000648048332c
FDA-2004-N-0569-0016 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 List of participants, attendees Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:45:32Z   0 0 090000648048332d
FDA-2004-N-0569-0007 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Transcript of November 15, 2004 Public Meeting Other TR-Transcript 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:46:18Z   0 0 090000648048330c
FDA-1994-P-0041-0248 FDA Require Labeling of Trans Fatty Acid & Prohibit Deceptive Claims-CLOSED FDA-1994-P-0041 HFA-305 to International Dairy Foods Association Other ACK-Acknowledgement Letter 2004-12-08T05:00:00Z 2004 12     2008-05-16T23:20:44Z   0 0 09000064804ff076
FDA-2004-N-0569-0008 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Transcript of November 15, 2004 Public Meeting Other TR-Transcript 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:45:11Z   0 0 090000648048330d
FDA-2004-N-0569-0009 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Agenda for November 15, 2004 meeting Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:43:40Z   0 0 090000648048330e
FDA-2004-N-0569-0010 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 Agenda for November 15, 2004 meeting Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:44:51Z   0 0 090000648048330f
FDA-1994-P-0041-0247 FDA Require Labeling of Trans Fatty Acid & Prohibit Deceptive Claims-CLOSED FDA-1994-P-0041 HFA-305 to International Dairy Foods Association Other ACK-Acknowledgement Letter 2004-12-08T05:00:00Z 2004 12     2008-05-16T23:20:54Z   0 0 09000064804ff075
FDA-2004-N-0569-0013 FDA Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting FDA-2004-N-0569 List of participants, attendees Other LST-List 2004-12-08T05:00:00Z 2004 12     2008-04-12T00:44:11Z   0 0 090000648048332a
FDA-2004-P-0409-0003 FDA Requesting FDA to declare that Benzonatate Capsules USP, 150 mg, is suitable for consideration in an abbreviated new drug application (ANDA)-CLOSED FDA-2004-P-0409 Citizen Petition Approval from FDA CDER to Lachman Consultant Services, Inc` Other Approval 2004-12-08T05:00:00Z 2004 12 2004-11-23T05:00:00Z   2025-02-13T19:34:13Z   0 0 090000648047458b
FDA-1997-S-0006-0099 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 HFS-800 to EuroPharma, Inc Other LET-Letter 2004-12-07T05:00:00Z 2004 12     2008-05-16T22:06:53Z   0 0 09000064805c98d9
FDA-1997-S-0006-0098 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 HFS-800 to Tianshi Health Products, Inc Other LET-Letter 2004-12-07T05:00:00Z 2004 12     2008-05-16T22:07:06Z   0 0 09000064805c98d8
FDA-1997-S-0006-0100 FDA Dietary Supplements, Courtesy Letters (Letters of Objection) FDA-1997-S-0006 HFS-800 to Leiner Health Products Other LET-Letter 2004-12-07T05:00:00Z 2004 12     2008-05-16T22:07:02Z   0 0 09000064805c98da
FDA-2004-P-0465-0001 FDA Request FDA Not Approve Any New or Pending ANDA or Application Filed Under Section 505)(b)(2) of the Act for A Generic Fentanyl Transdermal Product Which Is Not Supported By Either-CLOSED FDA-2004-P-0465 Acknowledgment Letter from FDA/DMB to London and Mead Other Acknowledgement Letter/Receipt 2004-12-07T05:00:00Z 2004 12 2004-12-07T05:00:00Z   2025-03-26T01:00:39Z   0 0 0900006480475877
FDA-2004-P-0465-0002 FDA Request FDA Not Approve Any New or Pending ANDA or Application Filed Under Section 505)(b)(2) of the Act for A Generic Fentanyl Transdermal Product Which Is Not Supported By Either-CLOSED FDA-2004-P-0465 Acknowledgment Letter from FDA/DMB to London and Mead Other Acknowledgement Letter/Receipt 2004-12-07T05:00:00Z 2004 12 2004-12-07T05:00:00Z   2025-03-25T22:10:49Z   0 0 09000064804758a1
FDA-2003-P-0015-0005 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Petition Denial from FDA CDER to Jerussi Consulting, Inc. Other PDN-Petition Denial 2004-12-06T05:00:00Z 2004 12 2004-12-02T05:00:00Z   2024-11-04T19:28:37Z   0 0 0900006480481346
FDA-2003-P-0348-0003 FDA make a determination that a Hydrocodone Bitartrate and Acetaminophen Tablet, USP 5 mg/300 mg combination drug product is suitable for submissin as an ANDA-CLOSED FDA-2003-P-0348 Petition Approval from FDA CDER to Lachman Consultant Services, Inc. Other PAV-Petition Approval 2004-12-06T05:00:00Z 2004 12 2004-11-23T05:00:00Z   2024-11-06T21:51:14Z   0 0 0900006480497058
FDA-2004-Q-0427-0003 FDA Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer FDA-2004-Q-0427 FDA Response to Fleminger, Inc - Letter Other ANS-Answer 2004-12-06T05:00:00Z 2004 12     2013-07-27T20:51:34Z   0 0 0900006480474806
FDA-2004-V-0232-0002 FDA Projector for a Laser Light Show FDA-2004-V-0232 Acknowledgement Letter to Tribal Existance Productions Other ACK-Acknowledgement Letter 2004-12-06T05:00:00Z 2004 12     2013-07-27T20:49:44Z   0 0 0900006480471883
FDA-2004-P-0149-0003 FDA petitioner requests the Commissioner to determine that NDA 19-44, Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for safety or effectiveness reasons FDA-2004-P-0149 Letter from FDA CDER to Abbott Laboratories Other Letter(s) 2004-12-06T05:00:00Z 2004 12 2004-11-30T05:00:00Z   2024-12-23T22:19:43Z   0 0 090000648046ff09
FDA-2004-V-0232-0001 FDA Projector for a Laser Light Show FDA-2004-V-0232 Acknowledgement Letter to Tribal Existance Productions Other ACK-Acknowledgement Letter 2004-12-06T05:00:00Z 2004 12     2013-07-27T20:49:44Z   0 0 0900006480471880
FDA-2004-Q-0427-0004 FDA Qualified health claim (QHC): Green Tea and Reduced Risk of Cancer FDA-2004-Q-0427 FDA Response to Mr. and Mrs. Richard James - Comment Other   2004-12-06T00:00:00Z 2004 12     2013-08-11T04:07:04Z   0 1 0900006480474807
FDA-2004-V-0166-0001 FDA Laser Light Show FDA-2004-V-0166 FDA/DDM to Forum Developers Limited Partnership Other ACK-Acknowledgement Letter 2004-12-03T05:00:00Z 2004 12     2008-04-12T00:53:08Z   0 0 0900006480470104
FDA-2004-V-0166-0002 FDA Laser Light Show FDA-2004-V-0166 FDA/DDM to Forum Developers Limited Partnership Other ACK-Acknowledgement Letter 2004-12-03T05:00:00Z 2004 12     2008-04-12T00:53:08Z   0 0 0900006480470109
FDA-1994-P-0023-0002 FDA Essential Use Exemption for Implantable Infusion Pump-CLOSED FDA-1994-P-0023 Citizen Petition Denial from FDA CDRH to MiniMed Technologies Other Denial of Petition 2004-12-03T05:00:00Z 2004 12     2024-07-29T17:37:19Z   0 0 09000064804fd1a4
FDA-2004-P-0275-0033 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:46Z   0 0 09000064804725ab
FDA-2004-P-0275-0015 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:39Z   0 0 0900006480472599
FDA-2004-P-0275-0012 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:39Z   0 0 0900006480472596
FDA-2004-P-0275-0016 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:50Z   0 0 090000648047259a
FDA-2004-P-0275-0022 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:45Z   0 0 09000064804725a0
FDA-2004-P-0275-0031 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:43Z   0 0 09000064804725a9
FDA-2004-P-0275-0026 FDA Health Claim Petition: Glucosamine & Chondroitin Sulfate & Osteoarthritis-CLOSED FDA-2004-P-0275 HF-22 Other LET-Letter 2004-12-02T05:00:00Z 2004 12     2008-04-12T00:48:45Z   0 0 09000064804725a4

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    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,
    object_id TEXT
);
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);