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55 rows where docket_id = "FDA-2021-N-0862" sorted by posted_date descending
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document_type 5
- Supporting & Related Material 44
- Other 5
- Rule 3
- Proposed Rule 2
- Notice 1
agency_id 1
- FDA 55
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2021-N-0862-0237 | FDA | None FDA-2021-N-0862 | Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals | Notice | Notice of Approval | 2025-09-25T04:00:00Z | 2025 | 9 | 2025-09-25T18:07:52Z | 2025-18621 | 0 | 0 | 09000064b8fdca45 | ||
| FDA-2021-N-0862-0236 | FDA | None FDA-2021-N-0862 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Rule | Final Rule | 2025-03-25T04:00:00Z | 2025 | 3 | 2025-03-25T14:47:53Z | 2025-04978 | 0 | 0 | 0900006486a2a7ed | ||
| FDA-2021-N-0862-0235 | FDA | None FDA-2021-N-0862 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Rule | Final Rule | 2025-01-27T05:00:00Z | 2025 | 1 | 2025-01-27T14:30:42Z | 2025-01840 | 0 | 0 | 0900006486900454 | ||
| FDA-2021-N-0862-0228 | FDA | None FDA-2021-N-0862 | Memorandum re Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Final Rule) | Other | Memo | 2025-01-23T05:00:00Z | 2025 | 1 | 2025-01-23T05:00:00Z | 2025-01-23T14:51:11Z | 0 | 0 | 09000064868c21c5 | ||
| FDA-2021-N-0862-0229 | FDA | None FDA-2021-N-0862 | TAB A-2023-142-ACNU-Final Rule-Original | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T18:59:12Z | 0 | 0 | 09000064868c2151 | |||
| FDA-2021-N-0862-0234 | FDA | None FDA-2021-N-0862 | TAB C-2023-142-ACNU-FRIA-Final | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T19:11:26Z | 0 | 0 | 09000064868c2155 | |||
| FDA-2021-N-0862-0232 | FDA | None FDA-2021-N-0862 | TAB B-2023-142-ACNU-FRIA-TRACK CHANGE FROM ORIGINAL TO FINAL | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T19:10:30Z | 0 | 0 | 09000064868c21cb | |||
| FDA-2021-N-0862-0231 | FDA | None FDA-2021-N-0862 | TAB B-2023-142-ACNU-Final Rule-TRACK CHANGE FROM ORIGINAL TO FINAL | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T19:04:00Z | 0 | 0 | 09000064868c2153 | |||
| FDA-2021-N-0862-0230 | FDA | None FDA-2021-N-0862 | TAB A-2023-142-ACNU-FRIA-Original | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T19:02:02Z | 0 | 0 | 09000064868c2152 | |||
| FDA-2021-N-0862-0233 | FDA | None FDA-2021-N-0862 | TAB C-2023-142-ACNU-Final Rule-Final | Supporting & Related Material | Background Material | 2025-01-15T05:00:00Z | 2025 | 1 | 2025-01-15T19:08:03Z | 0 | 0 | 09000064868c2154 | |||
| FDA-2021-N-0862-0219 | FDA | None FDA-2021-N-0862 | Reference 10 - FDA Combination Products web page | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2025-02-23T18:35:38Z | 0 | 0 | 090000648688c405 | |||
| FDA-2021-N-0862-0226 | FDA | None FDA-2021-N-0862 | Reference 18 - 73 FR 63491_Docket FDA-2008-N-0549_10-24-2008 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:49Z | 0 | 0 | 090000648688c497 | |||
| FDA-2021-N-0862-0227 | FDA | None FDA-2021-N-0862 | Reference 19 - 83 FR 40973_Docket FDA-2017-N-6730_08-17-2018 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:54Z | 0 | 0 | 090000648688c4a8 | |||
| FDA-2021-N-0862-0215 | FDA | None FDA-2021-N-0862 | Reference 7a - NPSA_Guide to Graphic Design of Medication Packaging 2nd Ed_2007 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:59:19Z | 0 | 0 | 090000648688c3cb | |||
| FDA-2021-N-0862-0218 | FDA | None FDA-2021-N-0862 | Reference 9 - FDA eCTD Resources web page | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2025-02-23T18:35:38Z | 0 | 0 | 090000648688c403 | |||
| FDA-2021-N-0862-0223 | FDA | None FDA-2021-N-0862 | Reference 15 - 83 FR 13394_Docket FDA-2008-N-0549_04-02-2018 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:19Z | 0 | 0 | 090000648688c490 | |||
| FDA-2021-N-0862-0225 | FDA | None FDA-2021-N-0862 | Reference 17 - 87 FR 68702_Docket FDA-2022-N-2673_11-16-2022 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:41Z | 0 | 0 | 090000648688c493 | |||
| FDA-2021-N-0862-0220 | FDA | None FDA-2021-N-0862 | Reference 11 - MOU Between the FTC and FDA Concerning the Exchange of Information (FDA-225-71-8003)_April 1971 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:59:53Z | 0 | 0 | 090000648688c406 | |||
| FDA-2021-N-0862-0217 | FDA | None FDA-2021-N-0862 | Reference 8 - USP_Recommendations to the Safe Medication Use Expert Committee by the Health Literacy and Prescription Container Labeling Advisory Panel_2010 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:59:32Z | 0 | 0 | 090000648688c402 | |||
| FDA-2021-N-0862-0208 | FDA | None FDA-2021-N-0862 | Reference List - Nonprescription Drug Product With an Additional Condition for Nonprescription Use - Final Rule | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:58:28Z | 0 | 0 | 090000648688c868 | |||
| FDA-2021-N-0862-0207 | FDA | None FDA-2021-N-0862 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Rule | Final Rule | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T05:00:00Z | 2024-12-26T15:41:32Z | 2024-30261 | 0 | 0 | 090000648688bfbc | |
| FDA-2021-N-0862-0216 | FDA | None FDA-2021-N-0862 | Reference 7b - NPSA_Guide to Labelling and Packaging of Injectable Medicines_1st Ed_2007 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:59:23Z | 0 | 0 | 090000648688c3cc | |||
| FDA-2021-N-0862-0209 | FDA | None FDA-2021-N-0862 | Reference 1 - FDA Guidance for Industry_Label -Comprehension-Studies-for-Nonprescription-Drug-Products_Aug2010 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:58:33Z | 0 | 0 | 090000648688c8ae | |||
| FDA-2021-N-0862-0212 | FDA | None FDA-2021-N-0862 | Reference 4 - FDA Guidance for Industry and FDA Staff_Policy for Device Software Functions and Mobile Medical Applications | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:58:49Z | 0 | 0 | 090000648688c8b3 | |||
| FDA-2021-N-0862-0213 | FDA | None FDA-2021-N-0862 | Reference 5 - FDA Medwatch The FDA Safety Information and Adverse Event Reporting Program | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2025-02-23T18:35:38Z | 0 | 0 | 090000648688c3c7 | |||
| FDA-2021-N-0862-0221 | FDA | None FDA-2021-N-0862 | Reference 12 - FDA Prescription to Over-the-Counter (OTC) Switch List web page | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2025-02-23T18:35:37Z | 0 | 0 | 090000648688c407 | |||
| FDA-2021-N-0862-0211 | FDA | None FDA-2021-N-0862 | Reference 3 - FDA Guidance for Industry_Application of Human Factors Engineering Principles for Combination Products QA_Sept2023 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:58:45Z | 0 | 0 | 090000648688c8b1 | |||
| FDA-2021-N-0862-0222 | FDA | None FDA-2021-N-0862 | Reference 14 - 87 FR 38313_Docket FDA-2021-N-0862_06-28-2022 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:08Z | 0 | 0 | 090000648688c986 | |||
| FDA-2021-N-0862-0224 | FDA | None FDA-2021-N-0862 | Reference 16 - 70 FR 52050_Docket 2005N-0345_09-01-2005 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T20:00:32Z | 0 | 0 | 090000648688c491 | |||
| FDA-2021-N-0862-0210 | FDA | None FDA-2021-N-0862 | Reference 2 - FDA Guidance for Industry_Self-Selection-Studies-for-Nonprescription-Drug-Products_April2013 | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2024-12-26T19:58:41Z | 0 | 0 | 090000648688c8b0 | |||
| FDA-2021-N-0862-0214 | FDA | None FDA-2021-N-0862 | Reference 6 - FDA Consumer Complaint Coordinators web page | Supporting & Related Material | Background Material | 2024-12-26T05:00:00Z | 2024 | 12 | 2025-02-23T18:35:38Z | 0 | 0 | 090000648688c3c8 | |||
| FDA-2021-N-0862-0206 | FDA | None FDA-2021-N-0862 | TAB C-NSURE-ProposedRule-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:50Z | 0 | 0 | 09000064855fd2fe | |||
| FDA-2021-N-0862-0203 | FDA | None FDA-2021-N-0862 | TAB B-2017-723-NSURERULE-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:31Z | 0 | 0 | 09000064855fd148 | |||
| FDA-2021-N-0862-0201 | FDA | None FDA-2021-N-0862 | TAB A-2017-723-NSURE-PRIA RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:18Z | 0 | 0 | 09000064855fd2fb | |||
| FDA-2021-N-0862-0204 | FDA | None FDA-2021-N-0862 | TAB B-NSURE-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:37Z | 0 | 0 | 09000064855fd149 | |||
| FDA-2021-N-0862-0205 | FDA | None FDA-2021-N-0862 | TAB C-NSURE-PRIA-Final RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:44Z | 0 | 0 | 09000064855fd2fd | |||
| FDA-2021-N-0862-0200 | FDA | None FDA-2021-N-0862 | Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Other | Memorandum | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T05:00:00Z | 2023-01-20T20:01:00Z | 0 | 0 | 09000064855fd0c5 | ||
| FDA-2021-N-0862-0202 | FDA | None FDA-2021-N-0862 | TAB A-2017-723-NSURERULE RE Memorandum - Nonprescription Drug Product With an Additional Condition for Nonprescription Use (Proposed Rule); Publication Date: June 28, 2022 | Supporting & Related Material | Background Material | 2023-01-20T05:00:00Z | 2023 | 1 | 2023-01-20T20:02:25Z | 0 | 0 | 09000064855fd147 | |||
| FDA-2021-N-0862-0177 | FDA | None FDA-2021-N-0862 | FDA Listening Session with APhA Stakeholders--High-Level Notes | Other | Meeting Exhibits | 2022-11-22T05:00:00Z | 2022 | 11 | 2022-11-22T05:00:00Z | 2022-11-26T04:59:59Z | 2022-11-22T20:15:53Z | 0 | 0 | 09000064854fc3fd | |
| FDA-2021-N-0862-0140 | FDA | None FDA-2021-N-0862 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period | Proposed Rule | Extension of Comment Period | 2022-10-24T04:00:00Z | 2022 | 10 | 2022-10-24T04:00:00Z | 2022-11-22T18:58:05Z | 2022-23033 | 0 | 0 | 090000648544cb97 | |
| FDA-2021-N-0862-0043 | FDA | None FDA-2021-N-0862 | Request for Extension from Consumer Healthcare Products Association | Other | Request for Extension | 2022-10-06T04:00:00Z | 2022 | 10 | 2022-10-06T04:00:00Z | 2022-11-22T18:57:53Z | 0 | 0 | 09000064853bd957 | ||
| FDA-2021-N-0862-0039 | FDA | None FDA-2021-N-0862 | Request for Extension from American Pharmacists Association | Other | Request for Extension | 2022-09-26T04:00:00Z | 2022 | 9 | 2022-09-26T04:00:00Z | 2022-11-22T18:57:40Z | 0 | 0 | 090000648536e90d | ||
| FDA-2021-N-0862-0001 | FDA | None FDA-2021-N-0862 | Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T04:00:00Z | 2022-11-26T04:59:59Z | 2024-08-23T01:00:37Z | 2022-13309 | 0 | 0 | 09000064851a6c55 |
| FDA-2021-N-0862-0008 | FDA | None FDA-2021-N-0862 | Reference 6- Engelberg Expert Workshop--Exploring Implications of the Nonprescription Drug Safe Use Regulatory Expansion Initiative on Reimbursement and Access_2013 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:48:58Z | 0 | 0 | 09000064851a6e08 | |||
| FDA-2021-N-0862-0011 | FDA | None FDA-2021-N-0862 | Reference 9 - 70 FR 52050 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:46:47Z | 0 | 0 | 09000064851a6e05 | |||
| FDA-2021-N-0862-0004 | FDA | None FDA-2021-N-0862 | Reference 2- Journal of Research in Pharmacy Practice re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:32:38Z | 0 | 0 | 09000064851a6e07 | |||
| FDA-2021-N-0862-0010 | FDA | None FDA-2021-N-0862 | Reference 8- 83 FR 13394 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:45:35Z | 0 | 0 | 09000064851a6e03 | |||
| FDA-2021-N-0862-0009 | FDA | None FDA-2021-N-0862 | Reference 7- FDA Preliminary Regulatory Impact Analysis_Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:43:52Z | 0 | 0 | 09000064851a6e04 | |||
| FDA-2021-N-0862-0005 | FDA | None FDA-2021-N-0862 | Reference 3- Guidance for Industry Label Comprehension Studies for Nonprescription Drug Products re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:34:10Z | 0 | 0 | 09000064851a56d6 | |||
| FDA-2021-N-0862-0007 | FDA | None FDA-2021-N-0862 | Reference 5- Engelberg Expert Workshop--Innovative Technologies and Nonprescription Medications--Addressing Undertreated Diseases and Conditions through Technology Enabled Self-Care re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:39:56Z | 0 | 0 | 09000064851a6e0a | |||
| FDA-2021-N-0862-0003 | FDA | None FDA-2021-N-0862 | Reference 1- Guidance for Industry Self-Selection Studies for Nonprescription Drug Products re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:30:20Z | 0 | 0 | 09000064851a56d8 | |||
| FDA-2021-N-0862-0013 | FDA | None FDA-2021-N-0862 | Reference 11 - 83 FR 33938 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:49:29Z | 0 | 0 | 09000064851a6e02 | |||
| FDA-2021-N-0862-0002 | FDA | None FDA-2021-N-0862 | Reference List re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:28:40Z | 0 | 0 | 09000064851a56d7 | |||
| FDA-2021-N-0862-0006 | FDA | None FDA-2021-N-0862 | Reference 4- Engleberg Expert Workshop--Nonprescription Medications With Conditions of Safe Use as a Novel Solution for Undertreated Diseases or conditions re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:38:18Z | 0 | 0 | 09000064851a6e06 | |||
| FDA-2021-N-0862-0012 | FDA | None FDA-2021-N-0862 | Reference 10 - 77 FR 12059 re: Nonprescription Drug Product With an Additional Condition for Nonprescription Use | Supporting & Related Material | Background Material | 2022-06-28T04:00:00Z | 2022 | 6 | 2022-06-28T13:49:16Z | 0 | 0 | 09000064851a6e09 |
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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;