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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2018-N-3240-1005 FDA List of Bulk Drug Substances For Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Notice FDA-2018-N-3240 Request for Extension from Collaborative for Evidence-Based Medicines Other Request for Extension 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:23:23Z   0 0 09000064b9329d1b
FDA-2026-V-4031-0001 FDA Laser Light Show FDA-2026-V-4031 Variance Application from David Wilson Other Application for Variance (VAR) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:07Z   0 0 09000064b927c69a
FDA-2004-V-0487-0012 FDA Laser Light Show FDA-2004-V-0487 Variance Approval Letter from FDA CDRH to Clark Planetarium Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T21:56:44Z   0 0 09000064b932a66a
FDA-2026-P-6789-0002 FDA Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population. FDA-2026-P-6789 Acknowledgement Letter from FDA DMB to Buchanan Ingersoll & Rooney PC Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-16T00:58:01Z   0 0 09000064b932ff3a
FDA-2026-V-4560-0002 FDA Laser Light Show FDA-2026-V-4560 Acknowledgment Letter from FDA DMB to DJZ Productions Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:27:57Z   0 0 09000064b92a571d
FDA-2026-P-4021-0003 FDA Requests that the FDA determine whether the Reference Listed Drug (RLD) SPORANOX (ITRACONAZOLE) Oral Solution, 10mg/mL; under New Drug Application (NDA) N020657 held by JANSSEN PHARMACEUTICALS INC, was voluntarily withdrawn from commercial distribution, or withdrawn from sale for safety or efficacy reasons. FDA-2026-P-4021 Final Response Other Letter(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:19:21Z   0 0 09000064b9328a95
FDA-2024-V-1078-0005 FDA Laser Light Show FDA-2024-V-1078 Variance Renewal Approval Letter from FDA CDRH to Dog From The Moon LLC Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:31:34Z   0 0 09000064b9326ee6
FDA-2025-P-7433-0005 FDA Requests that the FDA adopt, or incorporate into existing guidance, a risk-based regulatory framework specific to peptide therapeutics, with particular emphasis on delivery-route acceptability, dose sensitivity, and exposure variability. FDA-2025-P-7433 Interim Response from FDA CDER to University of Illinois, College of Pharmacy Other Response(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:48:58Z   0 0 09000064b93318f1
FDA-2026-D-2698-0002 FDA Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability FDA-2026-D-2698 Forms FDA 3542a and FDA 3542: Questions and Answers; Guidance for Industry Other Guidance 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z 2026-08-15T03:59:59Z 2026-06-15T17:14:02Z   1 0 09000064b932cc13
FDA-2026-H-6634-0001 FDA DAB Civil Money Penalty; Space Out Smoke Hickory LLC d/b/a Cosmic Smoke FDA-2026-H-6634 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:18:41Z   0 0 09000064b932ecff
FDA-2025-P-7112-0003 FDA Requests that FDA determine whether Fluosol® (20% Intravascular Perfluorochemical Emulsion) approved under New Drug Application (NDA) 86-0909, held by Alpha Therapeutic Corporation, has been voluntarily withdrawn from sale for reasons of safety or effectiveness, pursuant to 21 CFR S 314.161 FDA-2025-P-7112 Interim Response Other Letter(s) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:17:54Z   0 0 09000064b932a259
FDA-2020-V-1552-0007 FDA Laser Light Show FDA-2020-V-1552 Variance Amendment Approval Letter from FDA CDRH to LaserAnimation Sollinger GmbH Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:36:57Z   0 0 09000064b9327f85
FDA-2016-V-1231-0006 FDA Variance Request for Class IIIB laser Systems in the MAWL family of products: Models: MAWL-DA, MAWL-DA-B FDA-2016-V-1231 Variance Renewal Request from B.E. Meyers & Company, Inc. Other Request 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:16:59Z   0 0 09000064b932fd74
FDA-2026-V-4560-0001 FDA Laser Light Show FDA-2026-V-4560 Variance Application from DJZ Productions Other Application for Variance (VAR) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:27:28Z   0 0 09000064b92a571b
FDA-2026-H-6636-0001 FDA DAB Civil Money Penalty; Express II Corp. d/b/a Express Mart FDA-2026-H-6636 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:04:37Z   0 0 09000064b932fe34
FDA-2022-V-0385-0005 FDA Laser Light Show FDA-2022-V-0385 Variance Renewal Approval Letter to Brent Parrish Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:55:51Z   0 0 09000064b932fd52
FDA-2026-P-6789-0001 FDA Requests that the FDA review whether the two primary generic bicalutamide tablet suppliers can assure the safety, efficacy, and quality of bicalutamide tablets for the intended prostate cancer patient population. FDA-2026-P-6789 Citizen Petition from Buchanan Ingersoll & Rooney PC Other Citizen Petition 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-16T00:57:45Z   1 0 09000064b932ff38
FDA-2026-H-6519-0001 FDA DAB Civil Money Penalty; Victor H Ozuna d/b/a Vico's Drive Thru FDA-2026-H-6519 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T19:57:58Z   0 0 09000064b932eb25
FDA-2026-P-6737-0001 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Citizen Petition from Regina Sutton Other Citizen Petition 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:27:13Z   1 0 09000064b9329d15
FDA-2026-P-6737-0002 FDA Requests that the FDA grant an emergency moratorium of gadolinium use for public health and safety and establishment of a national use registry. FDA-2026-P-6737 Acknowledgement Letter from FDA DMB to Regina Sutton Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T20:27:18Z   0 0 09000064b9329d18
FDA-2026-V-4031-0002 FDA Laser Light Show FDA-2026-V-4031 Acknowledgment Letter from FDA DMB to David Wilson Other Acknowledgement Letter/Receipt 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:12Z   0 0 09000064b927c6a7
FDA-2026-H-6514-0001 FDA DAB Civil Money Penalty; Jorgui Corporation d/b/a Broadway Wine & Liquors FDA-2026-H-6514 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:07:07Z   0 0 09000064b9330744
FDA-2026-V-4031-0003 FDA Laser Light Show FDA-2026-V-4031 Variance Approval Letter to David Wilson Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:17Z   0 0 09000064b932fd41
FDA-2026-V-4560-0003 FDA Laser Light Show FDA-2026-V-4560 Variance Approval Letter from FDA CDRH to DJZ Productions Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:28:26Z   0 0 09000064b932e7fb
FDA-2024-V-4985-0005 FDA Laser Light Show FDA-2024-V-4985 Variance Approval Letter from FDA CDRH to Projectile Objects LLC Other Approval for Variance (VRA) 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T21:53:48Z   0 0 09000064b9329753
FDA-2024-V-1078-0004 FDA Laser Light Show FDA-2024-V-1078 Variance Renewal from Dog From the Moon LLC Other Request 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T22:31:13Z   0 0 09000064b93240f7
FDA-2026-H-6515-0001 FDA DAB Civil Money Penalty; Deyanira Izaguirre Martinez d/b/a Martinez Mini Mart & Taqueria FDA-2026-H-6515 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:17:28Z   0 0 09000064b9330741
FDA-2026-H-6513-0001 FDA DAB Civil Money Penalty; Nahkai - Ming Enterprise, LLC d/b/a Smoke House FDA-2026-H-6513 Complaint Other Complaint 2026-06-15T04:00:00Z 2026 6 2026-06-15T04:00:00Z   2026-06-15T23:19:07Z   0 0 09000064b933102e
FDA-2025-N-6692-0001 FDA NOOH Proposal to Debar Jeffrey Thies FDA-2025-N-6692 Notice Of Opportunity For Hearing - Thies Other Hearing/Meeting Summary 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:28:00Z   0 0 09000064b93284cb
FDA-2026-H-6520-0001 FDA DAB Civil Money Penalty; Broadway Convenience Inc. d/b/a Broadway Convenience FDA-2026-H-6520 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:51:15Z   0 0 09000064b9328a8e
FDA-2026-H-6521-0001 FDA DAB Civil Money Penalty; Broadway Gift Inc. d/b/a Broadway Gift Shop FDA-2026-H-6521 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:04:32Z   0 0 09000064b93284b7
FDA-2026-H-6511-0001 FDA DAB Civil Money Penalty; BD Supermarket LLC d/b/a BD Supermarket FDA-2026-H-6511 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:02:04Z   0 0 09000064b93265f1
FDA-2026-H-6401-0001 FDA DAB Civil Money Penalty; Los Trevi Drive-Thru, LLC d/b/a Los Trevi Drive-Thru 2 FDA-2026-H-6401 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:09:45Z   0 0 09000064b9325333
FDA-2026-H-6542-0001 FDA DAB Civil Money Penalty; La Florida Drive Thru LLC d/b/a La Florida Drive Thru FDA-2026-H-6542 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T23:27:56Z   0 0 09000064b9328064
FDA-2026-H-6205-0001 FDA DAB Civil Money Penalty; Cappello Bianco, Inc. d/b/a Il Bistro FDA-2026-H-6205 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:44:33Z   0 0 09000064b9327ea5
FDA-2026-H-6508-0001 FDA DAB Civil Money Penalty; Best Choice Liquor Co., LLC d/b/a Best Choice Grocery Liquors FDA-2026-H-6508 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T22:46:15Z   0 0 09000064b9326ea7
FDA-2026-H-6510-0001 FDA DAB Civil Money Penalty; 3 Guys of Tallahassee, LLC d/b/a Skyline Xpress / Marathon FDA-2026-H-6510 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:32:21Z   0 0 09000064b9327e99
FDA-2026-H-6545-0001 FDA DAB Civil Money Penalty; Sort Valley LLC d/b/a Mini Max Meat Market 3 FDA-2026-H-6545 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:10:18Z   0 0 09000064b93284bd
FDA-2026-H-6518-0001 FDA DAB Civil Money Penalty; Pynk Smoke LLC d/b/a Pynk Smoke FDA-2026-H-6518 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:01:29Z   0 0 09000064b93275de
FDA-2026-H-6517-0001 FDA DAB Civil Money Penalty; Bond Drugs, Inc. d/b/a Bond Drugs FDA-2026-H-6517 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:04:58Z   0 0 09000064b932551c
FDA-2026-H-6291-0001 FDA DAB Civil Money Penalty; S and H Convenience Inc. d/b/a Mr. Vapor Smoke Shop FDA-2026-H-6291 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:22:24Z   0 0 09000064b9328eb0
FDA-2026-H-6546-0001 FDA DAB Civil Money Penalty; Wal-Mart Stores East, LP d/b/a Walmart 1525 FDA-2026-H-6546 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:55:18Z   0 0 09000064b9329991
FDA-2026-H-5192-0001 FDA DAB Civil Money Penalty; Pierce Curby LLC d/b/a Holy Smokes FDA-2026-H-5192 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:19:35Z   0 0 09000064b9328e0a
FDA-2026-H-6507-0001 FDA DAB Civil Money Penalty; Moonachie Liquor LLC d/b/a Moonachie Liquors FDA-2026-H-6507 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T20:41:04Z   0 0 09000064b932998b
FDA-2026-H-6509-0001 FDA DAB Civil Money Penalty; Fort Lee Foodmart LLC d/b/a Shell / Food Mart / Mangia Thyme FDA-2026-H-6509 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:29:57Z   0 0 09000064b9325e2b
FDA-2026-H-6544-0001 FDA DAB Civil Money Penalty; Sinaloa DG LLC d/b/a Sinaloa Drive Thru 2 FDA-2026-H-6544 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T17:47:46Z   0 0 09000064b9327ec1
FDA-2026-R-6399-0001 FDA DAB No Tobacco Sale Order; Northwestern Highway & 12 Mile, Inc. d/b/a Marathon / Food Center FDA-2026-R-6399 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T18:55:26Z   0 0 09000064b932640d
FDA-2026-H-6543-0001 FDA DAB Civil Money Penalty; Lucky King 1 Corp. d/b/a Lucky King 1 FDA-2026-H-6543 Complaint Other Complaint 2026-06-12T04:00:00Z 2026 6 2026-06-12T04:00:00Z   2026-06-12T22:49:20Z   0 0 09000064b9327fd0
FDA-1998-P-0083-0025 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to American Board of Obstetrics & Gynecology Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:23:26Z   0 0 09000064b931e98f
FDA-2026-H-6387-0001 FDA DAB Civil Money Penalty; Pines Road Quick Stop LLC d/b/a Get-N-Geaux / Valero FDA-2026-H-6387 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T16:12:26Z   0 0 09000064b9322dd5
FDA-2026-H-6393-0001 FDA DAB Civil Money Penalty; B & Gajera LLC d/b/a Quick Mart FDA-2026-H-6393 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:29:57Z   0 0 09000064b9322c95
FDA-2026-H-6505-0001 FDA DAB Civil Money Penalty; Belleville Fuel Mart Inc. d/b/a Sunoco / FlexxMart FDA-2026-H-6505 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T19:29:23Z   0 0 09000064b9324f53
FDA-2026-V-5715-0002 FDA Laser Light Show FDA-2026-V-5715 Acknowledgment Letter from FDA DMB to Texas AVL Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:45:45Z   0 0 09000064b92dd1cb
FDA-2026-H-6506-0001 FDA DAB Civil Money Penalty; Hazal Tobacco 2 LLC d/b/a Tobacco Hut FDA-2026-H-6506 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:03:19Z   0 0 09000064b93263e1
FDA-1998-P-0083-0021 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Health Decisions, Inc. Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:12:43Z   0 0 09000064b931dd34
FDA-2026-V-5959-0002 FDA Laser Light Show FDA-2026-V-5959 Acknowledgment Letter from FDA DMB to Epic Productions LLC Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:44:12Z   0 0 09000064b92f03e6
FDA-2026-H-6397-0001 FDA DAB Civil Money Penalty; Al-Awwal Inc. d/b/a Tony’s Marathon / JK Food Mart FDA-2026-H-6397 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T19:27:03Z   0 0 09000064b9324f4c
FDA-2026-H-6390-0001 FDA DAB Civil Money Penalty; Farm Fresh of Carterville, Inc. d/b/a Farm Fresh FDA-2026-H-6390 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T20:02:30Z   0 0 09000064b9324bc9
FDA-2026-V-5715-0001 FDA Laser Light Show FDA-2026-V-5715 Variance Application from Texas AVL Other Application for Variance (VAR) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:45:40Z   0 0 09000064b92dd1ca
FDA-1998-P-0083-0031 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Edward L. Klaiber, M.D. Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:29:12Z   0 0 09000064b931e2f6
FDA-1998-P-0083-0029 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Harvard Medical School Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:27:25Z   0 0 09000064b931e2f0
FDA-2026-P-6706-0002 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Acknowledgement Letter from FDA DMB to Appco Pharma LLC Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:14:34Z   0 0 09000064b9324f5d
FDA-1998-P-0083-0019 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Morris Notelovitz M.D., Ph.D. Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:08:49Z   0 0 09000064b931dd31
FDA-1998-P-0083-0039 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to General Clinical Research Center Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T01:03:59Z   0 0 09000064b931ecf0
FDA-2026-V-4226-0002 FDA Laser Light Show FDA-2026-V-4226 Acknowledgment Letter from FDA DMB to Bean Lighting & Production Inc Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:46:19Z   0 0 09000064b92886e5
FDA-2026-V-4226-0003 FDA Laser Light Show FDA-2026-V-4226 Variance Approval Letter from FDA CDRH to Bean Lighting & Production Inc Other Approval for Variance (VRA) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:46:25Z   0 0 09000064b9322b61
FDA-2026-P-6706-0001 FDA Requests that the FDA declare that an ANDA may be submitted for, Modafinil Tablets, USP 50 mg and 150 mg, 2 strengths that differ from the currently approved RLD, PROVIGIL (Modafinil) tablets from NUVO PHARMACEUTICALS (IRELAND) DAC, which FDA approved in 100 mg and 200 mg strengths on Dec 24th, 1998 under NDA #020717. FDA-2026-P-6706 Suitability Petition from Appco Pharma LLC Other Petition(s) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:14:18Z   1 0 09000064b9324f5a
FDA-1998-P-0083-0033 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to George Washington University Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:31:56Z   0 0 09000064b931e2f9
FDA-2026-V-5959-0003 FDA Laser Light Show FDA-2026-V-5959 Variance Approval Letter from FDA CDRH to Epic Productions LLC Other Approval for Variance (VRA) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:44:17Z   0 0 09000064b9322bef
FDA-2026-P-6705-0001 FDA Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA) FDA-2026-P-6705 Suitability Petition from Argenta Other Petition(s) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T20:01:59Z   1 0 09000064b9322c33
FDA-1998-P-0083-0023 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Massachusetts General Hospital - Vincent Memorial Hospital Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:17:24Z   0 0 09000064b931de20
FDA-1998-P-0083-0015 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Acknowledgement Letter from FDA DMB to Solvay Pharmaceuticals Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:02:19Z   0 0 0900006480584b8b
FDA-2026-V-5715-0003 FDA Laser Light Show FDA-2026-V-5715 Variance Approval Letter to Texas AVL Other Approval for Variance (VRA) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:45:49Z   0 0 09000064b9324fed
FDA-1998-P-0083-0041 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to USC School of Medicine Women's Hospital Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T01:06:51Z   0 0 09000064b931ed33
FDA-2026-V-4226-0001 FDA Laser Light Show FDA-2026-V-4226 Variance Application from Bean Lighting & Production Inc Other Application for Variance (VAR) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:46:14Z   0 0 09000064b92886e3
FDA-2026-V-5959-0001 FDA Laser Light Show FDA-2026-V-5959 Variance Application from Epic Productions LLC Other Application for Variance (VAR) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:44:07Z   0 0 09000064b92f03e4
FDA-1998-P-0083-0027 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Prime Plus, Inc. Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:25:20Z   0 0 09000064b931e21b
FDA-1998-P-0083-0037 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to Mayo Clinic Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T01:02:06Z   0 0 09000064b931e996
FDA-2026-H-6396-0001 FDA DAB Civil Money Penalty; JTSS Partners, Inc. d/b/a Sequoia Smoke & Sundries; CLOSED 06/30/2026 FDA-2026-H-6396 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T15:45:48Z   0 0 09000064b9321ce4
FDA-2026-H-6394-0001 FDA DAB Civil Money Penalty; Ya Allah Madad LLC d/b/a Pink Clouds Smoke Shop 5 FDA-2026-H-6394 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T17:35:44Z   0 0 09000064b9324bc2
FDA-2026-P-6705-0002 FDA Request that the FDA declare that the drug product, generic ivermectin (1.87%) oral liquid is suitable for submission in an Abbreviated New Animal Drug Application (ANADA) FDA-2026-P-6705 Acknowledgment Letter from FDA DMB to Argenta Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T20:02:22Z   0 0 09000064b9322cb9
FDA-2026-H-6391-0001 FDA DAB Civil Money Penalty; Bright Stars Enterprises Inc. d/b/a Conway Food N Fuel / Phillips 66; CLOSED 06/17/2026 FDA-2026-H-6391 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T19:05:13Z   0 0 09000064b9324f14
FDA-2026-H-6371-0001 FDA DAB Civil Money Penalty; Smoke & Hookah Zone LLC d/b/a Smoke & Hookah Zone; CLOSED 6/26/2026 FDA-2026-H-6371 Complaint Other Complaint 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T19:56:54Z   0 0 09000064b9324fab
FDA-2026-V-6106-0003 FDA Laser Light Show FDA-2026-V-6106 Variance Approval Letter to Nightlight Photonics, LLC Other Approval for Variance (VRA) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:47:42Z   0 0 09000064b9325016
FDA-2026-V-6106-0001 FDA Laser Light Show FDA-2026-V-6106 Variance Application from Nightlight Photonics, LLC Other Application for Variance (VAR) 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:47:33Z   0 0 09000064b92f94b1
FDA-2026-V-6106-0002 FDA Laser Light Show FDA-2026-V-6106 Acknowledgment Letter from FDA DMB to Nightlight Photonics, LLC Other Acknowledgement Letter/Receipt 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-11T21:47:37Z   0 0 09000064b92f94b3
FDA-1998-P-0083-0017 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to University of Massachusetts Dept of Obstetrics and Gynecology Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:05:57Z   0 0 09000064b931dd2e
FDA-1998-P-0083-0014 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Citizen Petition from Solvay Pharmaceuticals Other Citizen Petition 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:01:41Z   0 0 0900006480584b78
FDA-1998-P-0083-0035 FDA Withdrawn From Sale of Tylosterone Tablets FDA-1998-P-0083 Answer Letter from FDA CDER to The Emory Clinic, Inc. Other Answer 2026-06-11T04:00:00Z 2026 6 2026-06-11T04:00:00Z   2026-06-12T00:33:31Z   0 0 09000064b931e31e
FDA-2026-V-5645-0001 FDA Laser Light Show FDA-2026-V-5645 Variance Application from Light Buds Productions Other Application for Variance (VAR) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:56:42Z   0 0 09000064b92d91ea
FDA-2026-V-5645-0002 FDA Laser Light Show FDA-2026-V-5645 Acknowledgment Letter from FDA DMB to Light Buds Productions Other Acknowledgement Letter/Receipt 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:56:46Z   0 0 09000064b92d91ec
FDA-2026-V-5957-0002 FDA Laser Light Show FDA-2026-V-5957 Variance Approval Letter to Laser Light Company Other Application for Variance (VAR) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:41:27Z   0 0 09000064b9321c4d
FDA-2021-P-0567-0006 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Response Letter Other Letter(s) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T22:15:38Z   0 0 09000064b931e217
FDA-2025-P-6831-4846 FDA Request that the FDA to revoke all BLA’s for every mRNA COVID-19 vaccine for all demographic groups because manufacturers do not and have never met BLA standards FDA-2025-P-6831 Interim Response Other Letter(s) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T22:07:53Z   0 0 09000064b931e215
FDA-2026-H-6388-0001 FDA DAB Civil Money Penalty; LBR LLC d/b/a Lickskillet Liquor FDA-2026-H-6388 Complaint Other Complaint 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T22:31:29Z   0 0 09000064b9323670
FDA-2026-V-5645-0003 FDA Laser Light Show FDA-2026-V-5645 Variance Approval Letter to Light Buds Productions Other Approval for Variance (VRA) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:56:51Z   0 0 09000064b932234e
FDA-2026-V-5821-0002 FDA Laser Light Show FDA-2026-V-5821 Acknowledgment Letter from FDA DMB to Vidz Lasers Other Acknowledgement Letter/Receipt 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:12:59Z   0 0 09000064b92e0ebd
FDA-2026-V-4804-0001 FDA Laser Light Show FDA-2026-V-4804 Variance Application from Privateer Other Application for Variance (VAR) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:01:19Z   0 0 09000064b92c17d3
FDA-2026-V-5821-0001 FDA Laser Light Show FDA-2026-V-5821 Variance Application from Vidz Lasers Other Application for Variance (VAR) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:12:51Z   0 0 09000064b92e0ebc
FDA-2026-V-4804-0002 FDA Laser Light Show FDA-2026-V-4804 Acknowledgment Letter from FDA DMB to Privateer Other Acknowledgement Letter/Receipt 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T18:01:24Z   0 0 09000064b92c17d7

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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,
    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);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;