documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
- comment_end_date
- A FULL UTC INSTANT, not a calendar date, despite the column name: '2026-08-29T03:59:59Z' is 11:59:59 PM EASTERN on 2026-08-28. Federal comment periods close at 11:59:59 PM Eastern, so the UTC calendar date is ONE DAY LATER than the official deadline on every end-of-day close — 444,689 of the 444,690 populated rows (measured 2026-09-06). Convert to America/New_York before presenting a deadline, and compare with julianday(comment_end_date) > julianday('now'): a plain > datetime('now') is a TEXT comparison between two different formats and keeps already-closed dockets matching for up to ~20 hours. The sibling column on open_comments.documents WAS corrected to an Eastern calendar date (queue #498); this one is unchanged and still an instant — the two databases do not agree on grain. (queue #644)
- comment_start_date
- A FULL UTC INSTANT, not a calendar date, despite the column name — same grain as comment_end_date on this table. Convert to America/New_York before presenting it. (queue #644)
3,534 rows where agency_id = "FDA", document_type = "Other" and posted_year = 2008 sorted by posted_date descending
This data as json, CSV (advanced)
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2007-V-0146-0007 | FDA | Laser Light Show FDA-2007-V-0146 | Acknowledgement Letter to Baylor University | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:33:53Z | 0 | 0 | 09000064807e13b2 | ||
| FDA-1999-V-4083-0007 | FDA | Laser Light Show Projector FDA-1999-V-4083 | FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance | Other | VRA-Approval for Variance | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:19Z | 0 | 0 | 09000064807e0d82 | ||
| FDA-2008-P-0343-0013 | FDA | Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED FDA-2008-P-0343 | Acknowledgement Letter to Novo Nordisk Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:25Z | 0 | 0 | 09000064807f8d4b | ||
| FDA-2008-P-0411-0009 | FDA | Require Any Repaglinide ANDAs Containing Only Section viii Statement for the '358' Patent to Convert to A Paragraph IV Certification or A Split-Certification-CLOSED FDA-2008-P-0411 | Novo Nordisk Inc. - Petition for Stay of Action | Other | PSA-Petition for Stay | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-08-11T02:58:51Z | 0 | 0 | 09000064807f9170 | ||
| FDA-2008-P-0411-0007 | FDA | Require Any Repaglinide ANDAs Containing Only Section viii Statement for the '358' Patent to Convert to A Paragraph IV Certification or A Split-Certification-CLOSED FDA-2008-P-0411 | Novo Nordisk Inc. - Petition for Reconsideration | Other | PRC-Petition for Reconsideration | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2009-06-18T16:54:55Z | 0 | 0 | 09000064807f8de8 | ||
| FDA-2008-P-0591-0003 | FDA | ANDA Suitablity Petition to Determine Whether a 1mg/mL (1mg/1mL, 3mg/3mL and 4mg/4mL) Topotecan Hydrochloride Injection Solution may be Filed as an Abbreviated New Drug Application - CLOSED FDA-2008-P-0591 | Regulus Pharmaceutical Consulting, Inc. - Amendment to Citizen Petition | Other | AMD-Amendment | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:24Z | 0 | 0 | 09000064807f25fd | ||
| FDA-2007-N-0475-0015 | FDA | Midodrine Exclusivity Issues FDA-2007-N-0475 | Mylan Pharmaceuticals, Inc. (Mylan) - Letter | Other | LET-Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T20:26:19Z | 0 | 0 | 09000064808094ec | ||
| FDA-2008-P-0343-0011 | FDA | Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED FDA-2008-P-0343 | Acknowledgement Letter to Novo Nordisk Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-08-11T04:30:35Z | 0 | 0 | 09000064807f915e | ||
| FDA-2008-P-0380-0004 | FDA | Requesting FDA Action on a "One Document Solution" for all Pharmacy-Based Communications - CLOSED FDA-2008-P-0380 | FDA/CDER Interim Response to National Association of Chain Drug Stores - Letter | Other | LET-Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:49Z | 0 | 0 | 09000064808094f2 | ||
| FDA-2008-P-0343-0012 | FDA | Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED FDA-2008-P-0343 | Novo Nordisk Inc. - Petition for Stay of Action | Other | PSA-Petition for Stay | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-08-11T02:58:51Z | 0 | 0 | 09000064807f9130 | ||
| FDA-1999-V-4083-0003 | FDA | Laser Light Show Projector FDA-1999-V-4083 | FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance | Other | VRA-Approval for Variance | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:14Z | 0 | 0 | 09000064804f5ec4 | ||
| FDA-1999-V-4083-0004 | FDA | Laser Light Show Projector FDA-1999-V-4083 | United Laser Artists, Inc. Request for Extension of Compliance Date | Other | EXP-Request for Extension of Compliance Date | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:15Z | 0 | 0 | 09000064804f5ec5 | ||
| FDA-2008-P-0660-0001 | FDA | Declare That the Drug Product, Carboplatin Injection, 10 mg/ mL in a 1000 mg/ 100 mL Multiple-Dose Vial, is Suitable for Consideration as an Abbreviated New Drug Application (ANDA) FDA-2008-P-0660 | OncoTherapies Limited - Citizen Petition | Other | CP-Citizen Petition | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:18Z | 0 | 0 | 09000064807eedcc | ||
| FDA-2008-P-0660-0002 | FDA | Declare That the Drug Product, Carboplatin Injection, 10 mg/ mL in a 1000 mg/ 100 mL Multiple-Dose Vial, is Suitable for Consideration as an Abbreviated New Drug Application (ANDA) FDA-2008-P-0660 | Acknowledgement Letter to OncoTherapies Limited | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-08-11T02:58:50Z | 0 | 0 | 09000064807ef0e8 | ||
| FDA-2008-P-0662-0002 | FDA | ANDA Suitability for Rifampkin Oral Suspension, 50 mg/5 mL and 10 mg/5 mL FDA-2008-P-0662 | Acknowledgement Letter to Lachman Consultant Services, Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-08-11T04:30:38Z | 0 | 0 | 09000064808080df | ||
| FDA-2007-P-0293-0004 | FDA | To Sanction Third Party Independent Scientific Analysis of Zine Gluconate (ZICAM) Additional Safety Standards for the Homeopathic Industry-CLOSED FDA-2007-P-0293 | Letter from David K. Richardson to FDA DMB | Other | Letter(s) | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2025-03-11T18:33:37Z | 0 | 0 | 09000064807df592 | ||
| FDA-1999-V-4083-0005 | FDA | Laser Light Show Projector FDA-1999-V-4083 | FDA/CDRH Response to United Laser Artists, Inc. - Approval for Variance | Other | VRA-Approval for Variance | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:16Z | 0 | 0 | 09000064804f5ec6 | ||
| FDA-1999-V-4083-0002 | FDA | Laser Light Show Projector FDA-1999-V-4083 | Acknowledgement Letter to United Laser Artists, Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:13Z | 0 | 0 | 09000064804f5ec3 | ||
| FDA-2008-P-0384-0004 | FDA | Petition Requesting a Follow-up Veterinary Medicine Advisory Committee Public Meeting be Scheduled Regarding the Return of ProHeart6 to the Market-CLOSED FDA-2008-P-0384 | FDA/CVM Interim Response to Laurie Rentas - Letter | Other | LET-Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T20:55:39Z | 0 | 0 | 09000064808094ee | ||
| FDA-2007-V-0146-0006 | FDA | Laser Light Show FDA-2007-V-0146 | Baylor University - Request for Extension of Compliance Date | Other | VAR-Application for Variance | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T19:03:28Z | 0 | 0 | 09000064807e0b96 | ||
| FDA-2007-N-0475-0009 | FDA | Midodrine Exclusivity Issues FDA-2007-N-0475 | FDA/CDER/OGD - "Response to Midodrine Application Holder" - Letter | Other | LET-Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2010-08-31T15:00:44Z | 0 | 0 | 0900006480439408 | ||
| FDA-2008-P-0411-0010 | FDA | Require Any Repaglinide ANDAs Containing Only Section viii Statement for the '358' Patent to Convert to A Paragraph IV Certification or A Split-Certification-CLOSED FDA-2008-P-0411 | Acknowledgement Letter to Novo Nordisk Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-28T01:58:06Z | 0 | 0 | 09000064807f8e2e | ||
| FDA-2008-P-0411-0008 | FDA | Require Any Repaglinide ANDAs Containing Only Section viii Statement for the '358' Patent to Convert to A Paragraph IV Certification or A Split-Certification-CLOSED FDA-2008-P-0411 | Acknowledgement Letter to Novo Nordisk Inc. | Other | ACK-Acknowledgement Letter | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:27Z | 0 | 0 | 09000064807f919e | ||
| FDA-1999-V-4083-0006 | FDA | Laser Light Show Projector FDA-1999-V-4083 | United Laser Artists, Inc. Request for Extension of Compliance Date | Other | EXP-Request for Extension of Compliance Date | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:18Z | 0 | 0 | 0900006480785a13 | ||
| FDA-2008-D-0053-0158 | FDA | Guidance for Industry on Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices FDA-2008-D-0053 | Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices Guidance for Industry | Other | Guidance | 2008-12-31T05:00:00Z | 2008 | 12 | 2020-05-13T04:00:00Z | 2024-11-06T23:36:21Z | 1 | 0 | 09000064845ef064 | ||
| FDA-2008-P-0662-0001 | FDA | ANDA Suitability for Rifampkin Oral Suspension, 50 mg/5 mL and 10 mg/5 mL FDA-2008-P-0662 | Lachman Consultant Services, Inc. - Citizen Petition | Other | CP-Citizen Petition | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2024-11-12T04:34:37Z | 1 | 0 | 09000064808080cb | ||
| FDA-2008-P-0343-0010 | FDA | Refrain from Approving Any Abbreviated New Drug Application (ANDA) for Repaglinide That Omits Crucial Information on Metformin Combination Therapy, Which is Protected by Patent & Currently Appears in the Labeling of the Innovator Product, PRANDIN-CLOSED FDA-2008-P-0343 | Novo Nordisk Inc. - Petition for Reconsideration | Other | PRC-Petition for Reconsideration | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2009-06-18T16:43:05Z | 0 | 0 | 09000064807f8ce8 | ||
| FDA-1999-V-4083-0001 | FDA | Laser Light Show Projector FDA-1999-V-4083 | United Laser Artists Inc. - Request for Variance | Other | VAR-Application for Variance | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2008-12-31T21:35:11Z | 0 | 0 | 09000064804f5ec2 | ||
| FDA-2008-P-0197-0004 | FDA | To Evaluate Tomatis Electronic Ear as Well as Other Simular Auditory Training Devices-CLOSED FDA-2008-P-0197 | FDA Response to William J. Kennick, Esq. - Petition Denial | Other | PDN-Petition Denial | 2008-12-31T05:00:00Z | 2008 | 12 | 2008-12-31T05:00:00Z | 2013-07-27T22:34:19Z | 0 | 0 | 09000064807eef30 | ||
| FDA-2008-P-0531-0129 | FDA | Citizen Petition to Ban Cornstarch Powder on Medical Gloves FDA-2008-P-0531 | Richard F. Edlich, M.D., Ph.D. - (University of Virginia Health System) - Supplement Citizen Petition | Other | SUP-Supplement | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2010-04-28T03:55:03Z | 0 | 0 | 09000064807de339 | ||
| FDA-2008-P-0605-0003 | FDA | Petition for Reconsideration Regarding Decision for 510K Application K081084 for FloWave 1000 FDA-2008-P-0605 | Woolsthorpe Technologies - Withdrawal of Petition for Reconsideration | Other | WDL-Withdrawal | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2008-12-30T22:03:15Z | 0 | 0 | 09000064807e388a | ||
| FDA-2008-P-0654-0001 | FDA | Refrain from Granting Effective Approval of An Over-the-Counter (OTC) Verison of Zegerid (Omeprazole/Sodium Bicarbonate)-CLOSED FDA-2008-P-0654 | Procter & Gamble Company - Citizen Petition | Other | CP-Citizen Petition | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2013-07-27T22:34:02Z | 0 | 0 | 09000064807e31cc | ||
| FDA-2008-P-0584-0002 | FDA | Determine that Prednisolone Sodium Phosphate Solution, in the Strength 30mg/5mL is Suitable for Consideration in an Abbreviated new Drug Application (ANDA) - CLOSED FDA-2008-P-0584 | Acknowledgement Letter to Cohen, Tauber, Spievack & Wagner P.C. | Other | ACK-Acknowledgement Letter | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2008-12-30T16:35:33Z | 0 | 0 | 09000064807a92f0 | ||
| FDA-1991-P-0058-0003 | FDA | Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 | FDA/CFSAN Response to Lois M. Meyer - Letter | Other | LET-Letter | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2013-07-28T01:58:00Z | 0 | 0 | 09000064807e383a | ||
| FDA-2008-N-0523-0005 | FDA | FDA Regulated Products that Contain Bisphenol-A; Request for Information FDA-2008-N-0523 | Plasma Protein Therapeutics Association (PPTA) - Request for Extension Comment Due Date | Other | EXT-Request for Extension Comment Due Date | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2013-07-27T22:34:14Z | 0 | 0 | 09000064807e8734 | ||
| FDA-2008-P-0358-0007 | FDA | Reclassify the Drug Terbutaline Sulfate From Pregnancy Risk Category B to Pregnancy Risk Category C, D, or X After Evalution of the Published Data (1,2) FDA-2008-P-0358 | Interim Response Letter from FDA/CDER to James P. Reichmann | Other | Letter(s) | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2015-10-08T13:03:39Z | 0 | 0 | 09000064807e37ba | ||
| FDA-2008-P-0368-0007 | FDA | Refuse to Approve Any Application for An Ophthalmic Drug Product Containing Bromfenac Sodium Submitted Under Section 505(j) or 505(b) of the Federal Food, Drug & Cosmetic Act Unless Specific Standards Are Satisfied-CLOSED FDA-2008-P-0368 | FDA/CDER Interim Response to ISTA Pharmaceuticals - Letter | Other | LET-Letter | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2008-12-31T00:25:10Z | 0 | 0 | 0900006480807c1c | ||
| FDA-1991-P-0058-0001 | FDA | Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 | Lois M. Meyer - Citizen Petition | Other | CP-Citizen Petition | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2013-07-28T01:42:43Z | 0 | 0 | 090000648052b9b2 | ||
| FDA-2008-P-0584-0001 | FDA | Determine that Prednisolone Sodium Phosphate Solution, in the Strength 30mg/5mL is Suitable for Consideration in an Abbreviated new Drug Application (ANDA) - CLOSED FDA-2008-P-0584 | Cohen, Tauber, Spievack & Wagner P.C - Citizen Petition | Other | CP-Citizen Petition | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2011-05-12T19:39:48Z | 0 | 0 | 09000064807a92d0 | ||
| FDA-2008-P-0654-0002 | FDA | Refrain from Granting Effective Approval of An Over-the-Counter (OTC) Verison of Zegerid (Omeprazole/Sodium Bicarbonate)-CLOSED FDA-2008-P-0654 | Acknowledgement Letter to Procter & Gamble Company | Other | ACK-Acknowledgement Letter | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2008-12-30T15:46:18Z | 0 | 0 | 09000064807e32ef | ||
| FDA-1991-P-0058-0002 | FDA | Amend Regulations for Food Labeling Print Size FDA-1991-P-0058 | Acknowledegement Letter to Lois M. Meyer | Other | ACK-Acknowledgement Letter | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2013-07-27T22:34:01Z | 0 | 0 | 09000064807e2f7c | ||
| FDA-1978-N-0018-0653 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Supplement from Energizer Personal Care (Playtex Products, Inc.) | Other | Supplement (SUP) | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2019-07-31T14:56:45Z | 0 | 0 | 09000064807df3d8 | ||
| FDA-2006-P-0149-0004 | FDA | Determine that FDA Would not Regulate as Medical Device Assays Developed by Clinical Laboratories Strictly for In-House use (Home Brew) FDA-2006-P-0149 | Citizen Petition from Washington Legal Foundation (WLF) | Other | Citizen Petition | 2008-12-30T05:00:00Z | 2008 | 12 | 2008-12-30T05:00:00Z | 2024-11-25T14:15:20Z | 1 | 0 | 09000064804504fa | ||
| FDA-2008-S-0350-0002 | FDA | Federal Registers, Written, and Electronic Submissions That do not include a Docket Number or ID - 2008 FDA-2008-S-0350 | Public Submissions without Docket Number or ID | Other | SPE-No Docket ID | 2008-12-24T05:00:00Z | 2008 | 12 | 2008-12-24T05:00:00Z | 2008-12-24T18:04:47Z | 0 | 0 | 09000064806279a5 | ||
| FDA-2005-P-0134-0004 | FDA | ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED FDA-2005-P-0134 | Petition Denial from FDA CDER to Lachman Consultant Services, Inc. | Other | PDN-Petition Denial | 2008-12-24T05:00:00Z | 2008 | 12 | 2008-12-24T05:00:00Z | 2024-11-12T18:26:40Z | 0 | 0 | 09000064807dcaef | ||
| FDA-2005-P-0134-0003 | FDA | ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Oral Solution USP, 5 mg/ 0.05 mg/5 mL - CLOSED FDA-2005-P-0134 | Citizens Petition from Lachman Consultant Services, Inc. | Other | CP-Citizen Petition | 2008-12-24T05:00:00Z | 2008 | 12 | 2008-12-24T05:00:00Z | 2024-11-12T18:24:31Z | 0 | 0 | 090000648043fe1e | ||
| FDA-2005-P-0381-0004 | FDA | ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Tablets USP 5 mg/0.05.mg-CLOSED FDA-2005-P-0381 | Petition Denial from FDA CDER to Lachman Consultant Services, Inc. | Other | PDN-Petition Denial | 2008-12-24T05:00:00Z | 2008 | 12 | 2008-12-24T05:00:00Z | 2024-11-12T17:54:02Z | 0 | 0 | 09000064807dcb48 | ||
| FDA-2005-P-0381-0003 | FDA | ANDA Suitability for Diphenoxylate Hydrochloride & Atropine Sulfate Tablets USP 5 mg/0.05.mg-CLOSED FDA-2005-P-0381 | Citizens Petition from Lachman Consultant Services, Inc. | Other | CP-Citizen Petition | 2008-12-24T05:00:00Z | 2008 | 12 | 2008-12-24T05:00:00Z | 2024-11-12T17:52:49Z | 0 | 0 | 090000648044bec6 | ||
| FDA-1994-N-0182-0048 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Transcript of the Pubic Hearing on Acyclovir - Transcript | Other | TR-Transcript | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:45Z | 0 | 0 | 090000648070b75e | ||
| FDA-1994-N-0182-0009 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | FDA "Dear Colleague" Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:01Z | 0 | 0 | 090000648050714a | ||
| FDA-1994-N-0182-0027 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Harvard Medical School - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:21Z | 0 | 0 | 0900006480507164 | ||
| FDA-1994-N-0182-0022 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Association of Reproductive Professional - Supplement | Other | SUP-Supplement | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:15Z | 0 | 0 | 090000648050715e | ||
| FDA-1994-N-0182-0005 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Distribution of FR Notice for Acyclovir Public Hearing - Memorandum | Other | M-Memorandum | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:00:57Z | 0 | 0 | 0900006480507146 | ||
| FDA-1994-N-0182-0040 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Social Health Association - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-08-11T02:40:17Z | 0 | 0 | 0900006480507187 | ||
| FDA-1978-N-0018-0644 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Citizen Petition from The International Center for Technology Assessment | Other | Citizen Petition | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-07-31T18:01:58Z | 0 | 0 | 090000648055a922 | ||
| FDA-1978-N-0018-0648 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Acknowledgment Letter from FDA to Ciba Corporation | Other | Acknowledgement Letter/Receipt | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-07-30T16:41:18Z | 0 | 0 | 09000064807d5c45 | ||
| FDA-1978-N-0018-0646 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Citizen Petition from Ciba Corporation | Other | Citizen Petition | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-08-02T01:01:01Z | 0 | 0 | 09000064807d5b6c | ||
| FDA-1994-N-0182-0003 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | FDA "Dear Colleague" Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:00:54Z | 0 | 0 | 0900006480507144 | ||
| FDA-1994-N-0182-0046 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - Memorandum | Other | M-Memorandum | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:43Z | 0 | 0 | 09000064805071be | ||
| FDA-1994-N-0182-0013 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Denise M. Buntin, M.D. - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-08-11T02:40:16Z | 0 | 0 | 0900006480507150 | ||
| FDA-1994-N-0182-0020 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Academy of Dermatology - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 090000648050715a | ||
| FDA-1994-N-0182-0031 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Nonprescription Drug Manufacturers Assn. - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:26Z | 0 | 0 | 090000648050716f | ||
| FDA-1994-N-0182-0030 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Center for Disease Control and Prevention - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:25Z | 0 | 0 | 090000648050716e | ||
| FDA-1994-N-0182-0049 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Index - List | Other | LST-List | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:47Z | 0 | 0 | 090000648070b89e | ||
| FDA-1978-N-0018-0645 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Citizen Petition from Schering-Plough Corporation | Other | Citizen Petition | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-07-30T16:47:54Z | 0 | 0 | 090000648055aa39 | ||
| FDA-1994-N-0182-0018 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | National Women's Health Network - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507156 | ||
| FDA-1994-N-0182-0026 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Infectious Diseases Society of America - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:20Z | 0 | 0 | 0900006480507163 | ||
| FDA-1994-N-0182-0007 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Distribution of FR Notice for Acyclovir Public Hearing - Memorandum | Other | M-Memorandum | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:00:59Z | 0 | 0 | 0900006480507148 | ||
| FDA-1994-N-0182-0006 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | FDA "Dear Colleague" Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:00:58Z | 0 | 0 | 0900006480507147 | ||
| FDA-1994-N-0182-0044 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Harvard Medical School - Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:41Z | 0 | 0 | 09000064805071aa | ||
| FDA-1994-N-0182-0019 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | University of Kansas Medical Center - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507157 | ||
| FDA-1994-N-0182-0015 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | The Center for Proper Medication Use - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507152 | ||
| FDA-1994-N-0182-0042 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-336 - Memorandum | Other | M-Memorandum | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:39Z | 0 | 0 | 0900006480507198 | ||
| FDA-1994-N-0182-0017 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | University of Pittsburgh - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507154 | ||
| FDA-1994-N-0182-0032 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Denise M. Buntin, M.D., P.C - Wthdrawal | Other | WDL-Withdrawal | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507171 | ||
| FDA-1994-N-0182-0021 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Infectious Diseases Society for Ob-Gyn - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 090000648050715b | ||
| FDA-1994-N-0182-0033 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - List | Other | LST-List | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:29Z | 0 | 0 | 0900006480507173 | ||
| FDA-1994-N-0182-0045 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - List | Other | LST-List | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:42Z | 0 | 0 | 09000064805071ab | ||
| FDA-1994-N-0182-0014 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | FDA "Dear Colleague" Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:07Z | 0 | 0 | 0900006480507151 | ||
| FDA-1994-N-0182-0034 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Nonprescription Drug Manufacturers Assn. - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:30Z | 0 | 0 | 0900006480507181 | ||
| FDA-1994-N-0182-0039 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Medical Women's Association - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:31Z | 0 | 0 | 0900006480507186 | ||
| FDA-1978-N-0018-0643 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Citizen Petition from Hawaiian Tropic Tanning Research Laboratories, Inc. | Other | Citizen Petition | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-07-30T13:21:07Z | 0 | 0 | 090000648055a8ae | ||
| FDA-1978-N-0018-0647 | FDA | Sunscreen Drug Products -OPEN FDA-1978-N-0018 | Letter from Home & Personal Care BL, Ciba Corporation to FDA/DDM | Other | Letter(s) | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2019-08-06T12:23:21Z | 0 | 0 | 09000064807d5bba | ||
| FDA-1994-N-0182-0012 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Association of Reproductive Health Professionals - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-28T01:40:44Z | 0 | 0 | 090000648050714f | ||
| FDA-1994-N-0182-0010 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | University of Washington School of Medicine - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:29Z | 0 | 0 | 090000648050714b | ||
| FDA-1994-N-0182-0016 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Society of Hospital Pharmacists - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-28T01:40:44Z | 0 | 0 | 0900006480507153 | ||
| FDA-1994-N-0182-0025 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - List | Other | LST-List | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:19Z | 0 | 0 | 0900006480507162 | ||
| FDA-1994-N-0182-0035 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Academy of Dermatology - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:31Z | 0 | 0 | 0900006480507182 | ||
| FDA-1994-N-0182-0036 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Assn. of Reproductive Health Professionals - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-28T01:40:45Z | 0 | 0 | 0900006480507183 | ||
| FDA-1994-N-0182-0028 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Center for Proper Medication Use - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:22Z | 0 | 0 | 090000648050716b | ||
| FDA-1994-N-0182-0008 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | FDA "Dear Colleague" Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:00Z | 0 | 0 | 0900006480507149 | ||
| FDA-2007-P-0061-0003 | FDA | Abbreviated New Drug Application (ANDA) Suitability for Memantine Hydrochloride Orally Disintegrating Tablets 5 mg and 10 mg-CLOSED FDA-2007-P-0061 | Orgenus Pharma, Inc./Attachments 1 and 2 - Amendment Petition | Other | AMD-Amendment | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T20:39:16Z | 0 | 0 | 0900006480429791 | ||
| FDA-1994-N-0182-0023 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | NANPRH - Supplement | Other | SUP-Supplement | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:17Z | 0 | 0 | 0900006480507160 | ||
| FDA-1994-N-0182-0024 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Medical Association - Appearance Request | Other | APE-Appearance Request | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-08-11T04:13:53Z | 0 | 0 | 0900006480507161 | ||
| FDA-1994-N-0182-0043 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - Letter | Other | LET-Letter | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:40Z | 0 | 0 | 09000064805071a6 | ||
| FDA-1994-N-0182-0029 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - List | Other | LST-List | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:23Z | 0 | 0 | 090000648050716c | ||
| FDA-1994-N-0182-0037 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Center for Proper Medication Use - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:31Z | 0 | 0 | 0900006480507184 | ||
| FDA-1994-N-0182-0038 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | American Society of Hospital Pharmacists - Testimony | Other | TS-Testimony | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2013-07-27T21:20:31Z | 0 | 0 | 0900006480507185 | ||
| FDA-1994-N-0182-0047 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | HFD-9 - Memorandum of Meeting | Other | MM-Memorandum of Meeting | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:44Z | 0 | 0 | 09000064805071c1 | ||
| FDA-1994-N-0182-0041 | FDA | Proposed Switch of Acyclovir from Prescription to OTC Status FDA-1994-N-0182 | Univeristy of Florida - Supplement | Other | SUP-Supplement | 2008-12-23T05:00:00Z | 2008 | 12 | 2008-12-23T05:00:00Z | 2008-12-23T21:01:38Z | 0 | 0 | 0900006480507193 |
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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;