documents

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

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

65 rows where document_type = "Other" and posted_year = 2001 sorted by posted_date descending

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posted_year 1

  • 2001 · 65 ✖

document_type 1

  • Other · 65 ✖

agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2001-P-0155-0001 FDA Requirement of ANDA for Mixed Salts of Single Entity Amphetamine-CLOSED FDA-2001-P-0155 FDA/DDM to Arnall, Golden Gregory Other ACK-Acknowledgement Letter 2001-12-27T05:00:00Z 2001 12     2008-04-25T02:27:48Z   0 0 09000064804df043
FDA-2001-P-0053-0001 FDA New and/or Amended Regulations for BPCA-CLOSED FDA-2001-P-0053 Acknowledgment Letter from FDA DMB to Wilmer, Cutler & Pickering Other Acknowledgement Letter/Receipt 2001-12-27T05:00:00Z 2001 12     2024-09-23T22:37:14Z   0 0 09000064804b7e38
FDA-2001-P-0452-0001 FDA ANDA Suitability for a Change in Dosage Form for Imuren-CLOSED FDA-2001-P-0452 Approval Letter from FDA CDER to AA1 International Other Approval 2001-12-17T05:00:00Z 2001 12 2021-01-28T05:00:00Z   2021-02-01T17:19:08Z   0 0 0900006484a0af87
FDA-2001-P-0191-0001 FDA Refrain Approval of Any Buprenorphine Product-CLOSED FDA-2001-P-0191 FDA/DDM to Hogan & Hartson, LLP Other ACK-Acknowledgement Letter 2001-12-11T05:00:00Z 2001 12     2008-04-25T02:25:58Z   0 0 09000064804e2665
FDA-2001-P-0215-0002 FDA Determine whether Sotradecol has been withdrawn from sale in FDA-2001-P-0215 Acknowledgment Letter from FDA DMB to Omega Laboratories, Ltd. Other ACK-Acknowledgement Letter 2001-12-07T05:00:00Z 2001 12     2024-08-23T13:49:30Z   0 0 09000064804e488d
FDA-2001-P-0086-0002 FDA Dissemination of Non-Misleading Information/Off-Label Uses-CLOSED FDA-2001-P-0086 FDA/OC to Washington Legal Foundation Other LET-Letter 2001-11-27T05:00:00Z 2001 11     2008-04-25T02:23:19Z   0 0 09000064804b8543
FDA-1978-N-0018-0440 FDA Sunscreen Drug Products -OPEN FDA-1978-N-0018 Memorandum of Meeting Between FDA/OCC and Cosmetic, Toiletry and Fragrance Association Other Memorandum 2001-11-19T05:00:00Z 2001 11     2019-08-07T12:11:46Z   0 0 090000648055a7fe
FDA-1980-N-0074-0075 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 FDA/ORA to Colgate-Palmolive Company Other PDN-Petition Denial 2001-11-14T05:00:00Z 2001 11     2008-05-30T22:52:47Z   0 0 09000064805bb4db
FDA-2018-D-4115-0013 FDA FDA-2018-D-4115 The Mammography Quality Standards Act Final Regulations: Preparing For MQSA Inspections; Final Guidance for Industry and FDA Other Guidance 2001-11-04T05:00:00Z 2001 11 2001-11-04T05:00:00Z   2024-11-06T23:36:50Z   1 0 0900006484644a3f
FDA-2001-P-0239-0005 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Letter from FDA CFSAN to Krislov & Associates, LTD. Other Letter(s) 2001-10-31T05:00:00Z 2001 10 2020-07-06T04:00:00Z   2024-09-09T17:22:16Z   0 0 09000064804e6814
FDA-2001-P-0239-0004 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Letter from FDA CFSAN to Center for Food Safety Other Letter(s) 2001-10-31T05:00:00Z 2001 10 2020-07-06T04:00:00Z   2024-09-09T17:22:06Z   0 0 09000064804e6812
FDA-1999-P-0059-0004 FDA Reg/Guide to Label Medical Devices contain'g Phthalate Plasticizers-CLOSED FDA-1999-P-0059 FDA/DMB to Health Care Without Harm Other ACK-Acknowledgement Letter 2001-10-05T04:00:00Z 2001 10     2008-04-25T00:13:56Z   0 0 09000064804a671c
FDA-1996-P-0041-0001 FDA Refrain from granting exclusivity to NDAs for Fexofenadine FDA-1996-P-0041 Memorandum from FDA, Dave Read (HFD-7) to FDA Dockets Management Branch (HFA-305) Other Memorandum 2001-09-19T04:00:00Z 2001 9     2024-06-20T14:22:26Z   0 0 09000064804fc5e9
FDA-2001-E-0027-0001 FDA Angiomax, Patent Term Extension Application, No. 5,196,404 FDA-2001-E-0027 FDA/CDER to the U. S. Patent & Trademark Office - Letter Other LET-Letter 2001-09-12T04:00:00Z 2001 9     2010-01-29T15:43:16Z   0 0 09000064804b5c4f
FDA-2001-P-0216-0002 FDA To Remove False and Deceptive Labeling for Transderm Scope-CLOSED FDA-2001-P-0216 FDA/CDER to Paul, Hastings, Janofsky & Walker LLP Other LET-Letter 2001-09-11T04:00:00Z 2001 9     2008-04-25T02:38:56Z   0 0 09000064804e4a25
FDA-1999-P-0059-0003 FDA Reg/Guide to Label Medical Devices contain'g Phthalate Plasticizers-CLOSED FDA-1999-P-0059 FDA/CDRH to Sanford J. Lewis Other PDN-Petition Denial 2001-09-11T04:00:00Z 2001 9     2008-04-25T00:13:56Z   0 0 09000064804a671a
FDA-2001-P-0001-0002 FDA Rescind Approval of Solid Oral Dosage form of Metaxalone-CLOSED FDA-2001-P-0001 FDA/CDER to Mutual Pharmaceutical Company Other LET-Letter 2001-09-11T04:00:00Z 2001 9     2008-04-25T02:25:38Z   0 0 09000064804b3acf
FDA-2001-P-0056-0003 FDA Hydrocodone Bitartrate and Acetaminophen Products-CLOSED FDA-2001-P-0056 FDA/CDER to Pharmaceutical Associates Inc Other PAV-Petition Approval 2001-08-27T04:00:00Z 2001 8     2008-04-25T01:57:35Z   0 0 09000064804b7ec8
FDA-2001-P-0239-0003 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Amendment from Krislov & Associates, LTD. Other Amendment 2001-08-23T04:00:00Z 2001 8 2020-07-06T04:00:00Z   2020-07-06T22:32:12Z   0 0 09000064804e680f
FDA-1999-N-0113-0168 FDA Vibrio Parahaemolyticus in molluscan shellfish public health FDA-1999-N-0113 Draft Agenda for March 20, 2001 meeting Other LST-List 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:17:47Z   0 0 09000064804ae795
FDA-1999-N-0134-0009 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 HHS/USDA Action Plan Other TS-Testimony 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:16:59Z   0 0 09000064804aebb5
FDA-1999-N-0113-0169 FDA Vibrio Parahaemolyticus in molluscan shellfish public health FDA-1999-N-0113 Summary of the Draft Risk Assessment Other TS-Testimony 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:17:45Z   0 0 09000064804ae798
FDA-1999-N-0134-0007 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 Listeriosis in the United States Other TS-Testimony 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:17:00Z   0 0 09000064804aebb3
FDA-1999-N-0134-0006 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 Agenda for March 19, 2001 Public Meeting Other LST-List 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:17:00Z   0 0 09000064804aebb2
FDA-1999-N-0134-0008 FDA Public Health Impact of Foodborne Listeria Monocytogenes FDA-1999-N-0134 Draft Assessment of the Relative Risk Other TS-Testimony 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:16:58Z   0 0 09000064804aebb4
FDA-1999-N-0113-0170 FDA Vibrio Parahaemolyticus in molluscan shellfish public health FDA-1999-N-0113 Risk Reduction Strategy for Vibrio parahaemolyticus Other TS-Testimony 2001-08-03T04:00:00Z 2001 8     2008-04-25T00:17:41Z   0 0 09000064804ae79b
FDA-2001-P-0190-0001 FDA Revoke Invalid FDA Regulations-CLOSED FDA-2001-P-0190 FDA/DDM to Washington Legal Foundation Other ACK-Acknowledgement Letter 2001-08-01T04:00:00Z 2001 8     2008-04-25T02:27:37Z   0 0 09000064804e2531
FDA-2001-P-0156-0002 FDA Request to file an ANDA for Ifosfamide for Injection FDA-2001-P-0156 FDA/CDER to Tom Stothoff Other LET-Letter 2001-07-27T04:00:00Z 2001 7     2008-04-25T02:25:53Z   0 0 09000064804df2a0
FDA-2001-P-0152-0001 FDA Withdrawal of product from sale in the US FDA-2001-P-0152 FDA/DDM Other ACK-Acknowledgement Letter 2001-07-25T04:00:00Z 2001 7     2008-04-25T02:27:08Z   0 0 09000064804ddd42
FDA-2001-P-0126-0001 FDA Anda Suitability Petition for TestoCreme 5% (Testosterone)-CLOSED FDA-2001-P-0126 FDA/DDM to TestoCreme, LLC Other ACK-Acknowledgement Letter 2001-07-13T04:00:00Z 2001 7     2008-04-25T02:27:41Z   0 0 09000064804dd948
FDA-2000-P-0151-0002 FDA Amend definition & standard of identity for parmesan cheese-CLOSED FDA-2000-P-0151 FDA/CFSAN to Sartori Food Corp. Other LET-Letter 2001-07-11T04:00:00Z 2001 7     2008-04-25T01:31:51Z   0 0 09000064804d117f
FDA-1980-N-0074-0073 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 FDA/ORA to Hyman, Phelps & McNamara, P. C. Other PDN-Petition Denial 2001-07-09T04:00:00Z 2001 7     2008-05-30T22:53:22Z   0 0 09000064805bb4d8
FDA-2001-P-0125-0001 FDA ANDA Suitability Petition for Fluorouracil Topital Solution-CLOSED FDA-2001-P-0125 FDA/DMB to Ferndale Laboratories Inc. Other ACK-Acknowledgement Letter 2001-07-02T04:00:00Z 2001 7     2008-04-25T02:26:16Z   0 0 09000064804dd914
FDA-2001-P-0055-0001 FDA ANDA Suitability for Topical Cream Containing 5% Lidocaine-CLOSED FDA-2001-P-0055 FDA/DDM to Ferndale Laboratories, Inc. Other ACK-Acknowledgement Letter 2001-07-02T04:00:00Z 2001 7     2008-04-25T01:57:35Z   0 0 09000064804b7e8a
FDA-2020-D-1954-0001 FDA FDA-2020-D-1954 Small Entity Compliance Guide: Safe Handling Statements on Labeling of Shell Eggs and the Refrigeration of Shell Eggs Held for Retail Distribution Other Guidance 2001-07-01T04:00:00Z 2001 7 2020-09-21T04:00:00Z   2024-11-12T23:24:58Z   1 0 090000648486938a
FDA-2000-D-0278-0001 FDA Refusal of Inspection or Access to HACCP recods pertaining FDA-2000-D-0278 Guidance for Industry: Refusal of Inspection or Access to HACCP Records Pertaining to the Safe and Sanitary Processing of Fish and Fishery Products Other Guidance 2001-07-01T04:00:00Z 2001 7 2020-09-29T04:00:00Z   2024-11-06T23:39:12Z   1 0 090000648489ae28
FDA-2020-D-1955-0001 FDA FDA-2020-D-1955 Small Entity Compliance Guide: Serving Sizes Reference Amount for Baking Powder, Baking Soda, and Pectin Other Guidance 2001-07-01T04:00:00Z 2001 7 2020-09-21T04:00:00Z   2024-11-06T23:39:28Z   1 0 090000648486938c
FDA-1980-N-0074-0072 FDA Anticaries Drug Products for OTC Human Use; FDA-1980-N-0074 HFD-560 to Warner Lambert Consumer Healthcare Other LET-Letter 2001-06-28T04:00:00Z 2001 6     2008-05-30T22:53:09Z   0 0 09000064805bb4d7
FDA-2001-P-0088-0001 FDA ANDA for Pentoxifylline Extended-release Tablets, 500 mg.-CLOSED FDA-2001-P-0088 FDA/DDM to the Weinberg Group Inc. Other ACK-Acknowledgement Letter 2001-06-26T04:00:00Z 2001 6     2008-04-25T02:24:43Z   0 0 09000064804b8615
FDA-2001-P-0124-0001 FDA Reformat label for prescription drug for asthma medication-CLOSED FDA-2001-P-0124 FDA/DDM to GlaxoSmithKline Other ACK-Acknowledgement Letter 2001-06-14T04:00:00Z 2001 6     2008-04-25T02:25:49Z   0 0 09000064804dd8dc
FDA-2001-P-0193-0001 FDA ANDA Suitability for Dextroamphetamine Sulfate Tablets 15 mg FDA-2001-P-0193 FDA/DDM to Mallinckrodt, Inc. Other ACK-Acknowledgement Letter 2001-05-30T04:00:00Z 2001 5     2008-04-25T02:27:23Z   0 0 09000064804e2a9e
FDA-2001-P-0086-0001 FDA Dissemination of Non-Misleading Information/Off-Label Uses-CLOSED FDA-2001-P-0086 FDA/DDM to Washington Legal Foundation Other ACK-Acknowledgement Letter 2001-05-30T04:00:00Z 2001 5     2008-04-25T02:23:19Z   0 0 09000064804b8533
FDA-2001-P-0090-0001 FDA Reclassification of Cyclosporine Immunoassay-CLOSED FDA-2001-P-0090 FDA/DDM to Devices & Diagnostics Consulting Group, Inc. Other ACK-Acknowledgement Letter 2001-05-17T04:00:00Z 2001 5     2008-04-25T02:24:05Z   0 0 09000064804b89a6
FDA-1998-P-0046-0002 FDA Revoke determination that TSRH Pedicle Spinal Screw System-CLOSED FDA-1998-P-0046 FDA/CDRH to Levin Fishbein Sedran & Berman Other PDN-Petition Denial 2001-05-16T04:00:00Z 2001 5     2008-05-16T21:47:38Z   0 0 090000648056e6f7
FDA-1998-P-0018-0004 FDA Drug products containing oxycodone hydrocloride tablet suitable-CLOSED FDA-1998-P-0018 Citizen Petition Denial from FDA CDER to King & Spalding Other Denial of Petition 2001-05-10T04:00:00Z 2001 5     2024-07-12T16:59:04Z   0 0 0900006480563c55
FDA-2000-P-0024-0003 FDA ANDA Suitability for Hydrocodone Bitartrate/Acetaminophen-CLOSED FDA-2000-P-0024 FDA/CDER to Pharmaceutical Associates Inc Other PDN-Petition Denial 2001-05-10T04:00:00Z 2001 5     2008-04-25T01:13:49Z   0 0 09000064804aea00
FDA-2000-P-0212-0002 FDA Remove Unapproved Children's Fluoride Supplements from Mkt FDA-2000-P-0212 FDA/CDER to New Jersey General Assembly Other LET-Letter 2001-05-08T04:00:00Z 2001 5     2008-04-25T01:47:09Z   0 0 09000064804d4d8f
FDA-2001-P-0030-0001 FDA Prescription Drug Products List Amendment & Approve New Dosage-CLOSED FDA-2001-P-0030 Acknowledgement Letter to Duramed Pharmaceuticals Inc. Other ACK-Acknowledgement Letter 2001-05-02T04:00:00Z 2001 5     2010-03-11T23:01:24Z   0 0 09000064804b602e
FDA-2001-P-0056-0002 FDA Hydrocodone Bitartrate and Acetaminophen Products-CLOSED FDA-2001-P-0056 FDA/DDM to Pharmaceutical Associates, Inc. Other ACK-Acknowledgement Letter 2001-04-25T04:00:00Z 2001 4     2008-04-25T01:57:35Z   0 0 09000064804b7ec7
FDA-2001-P-0239-0001 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Citizen Petition from Krislov & Associates, LTD. Other Citizen Petition 2001-04-23T04:00:00Z 2001 4 2020-07-06T04:00:00Z   2024-07-29T20:36:46Z   0 0 09000064804e67f9
FDA-2001-P-0239-0002 FDA Fountain Diet Coca-Cola and Bottled Diet Coca-Cola FDA-2001-P-0239 Acknowledgment Letter from FDA DMB to Krislov & Associates, LTD. Other Acknowledgement Letter/Receipt 2001-04-23T04:00:00Z 2001 4 2020-07-06T04:00:00Z   2024-09-09T17:21:36Z   0 0 09000064804e680d
FDA-2000-D-0067-0002 FDA Medical Device Patient Labeling FDA-2000-D-0067 Guidance on Medical Device Patient Labeling: Final Guidance for Industry and FDA Staff Other Guidance 2001-04-19T04:00:00Z 2001 4 2001-04-19T04:00:00Z   2024-11-11T21:01:40Z   1 0 0900006481b68183
FDA-1999-D-0188-0002 FDA Efficacy of Anthelmintics for Bovines, Ovines, & Caprines FDA-1999-D-0188 Guidance for Industry Effect of Anthelmintics : Specific Recommendations for Ovine VICH GL13 - Final Guidance 96 Other Guidance 2001-04-11T04:00:00Z 2001 4 2001-03-26T05:00:00Z   2020-04-30T19:51:36Z   0 0 09000064804b04a6
FDA-1999-D-0188-0001 FDA Efficacy of Anthelmintics for Bovines, Ovines, & Caprines FDA-1999-D-0188 Guidance for Industry Effectiveness of Anthelmintics: Specific Recommendations for Bovine VICH GL12 - Final Guidance 95 Other Guidance 2001-04-11T04:00:00Z 2001 4 2001-03-26T05:00:00Z   2020-04-30T19:50:46Z   0 0 09000064804b04a5
FDA-1999-D-0188-0003 FDA Efficacy of Anthelmintics for Bovines, Ovines, & Caprines FDA-1999-D-0188 Guidance for Industry Effect of Anthelmintics : Specific Recommendations for Caprine VICH GL14 - Final Guidance 97 Other Guidance 2001-04-11T04:00:00Z 2001 4 2001-03-26T05:00:00Z   2020-04-30T19:52:20Z   0 0 09000064804b04a8
FDA-2000-P-0096-0003 FDA Approve ANDA for Cefuroxime Axetil Products-CLOSED FDA-2000-P-0096 FDA/CDER to Arnold & Porter Other LET-Letter 2001-04-09T04:00:00Z 2001 4     2008-04-25T01:01:16Z   0 0 09000064804b822d
FDA-2001-P-0214-0001 FDA Magnification Devices FDA-2001-P-0214 FDA/DDM to Veigh Hogan Jr. Other ACK-Acknowledgement Letter 2001-04-03T04:00:00Z 2001 4     2008-04-25T02:37:12Z   0 0 09000064804e4703
FDA-2001-P-0189-0001 FDA ANDA filed for Midazolam Injection (Preservative Free)-CLOSED FDA-2001-P-0189 FDA/CDER to Abbott Laboratories Other ACK-Acknowledgement Letter 2001-03-21T05:00:00Z 2001 3     2008-04-25T02:27:15Z   0 0 09000064804e23fa
FDA-2001-P-0056-0001 FDA Hydrocodone Bitartrate and Acetaminophen Products-CLOSED FDA-2001-P-0056 FDA/DDM to Pharmaceutical Associates, Inc. Other ACK-Acknowledgement Letter 2001-03-16T05:00:00Z 2001 3     2008-04-25T01:57:35Z   0 0 09000064804b7ebe
FDA-2001-D-0506-0002 FDA Postmarketing Safety Reporting-Human Drug & Biological Products Including Vaccines FDA-2001-D-0506 Draft Guidance for Industry on Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines; Guidance Document Other Guidance 2001-03-09T05:00:00Z 2001 3     2024-11-07T21:53:22Z   1 0 09000064804ef97f
FDA-2001-P-0216-0001 FDA To Remove False and Deceptive Labeling for Transderm Scope-CLOSED FDA-2001-P-0216 FDA/DDM to Paul, Hastings, Janofsky & Walker LLP Other ACK-Acknowledgement Letter 2001-03-08T05:00:00Z 2001 3     2008-04-25T02:38:56Z   0 0 09000064804e4970
FDA-2001-P-0194-0001 FDA Reclass. Cyclosporine Diagnostic Test Devices from Class III FDA-2001-P-0194 FDA/DDM to Dade Behring Inc. Other ACK-Acknowledgement Letter 2001-03-06T05:00:00Z 2001 3     2008-04-25T02:38:06Z   0 0 09000064804e2bef
FDA-2001-P-0001-0001 FDA Rescind Approval of Solid Oral Dosage form of Metaxalone-CLOSED FDA-2001-P-0001 FDA/DDM to Mutual Pharmaceutical Company. Inc. Other ACK-Acknowledgement Letter 2001-03-06T05:00:00Z 2001 3     2008-04-25T02:25:38Z   0 0 09000064804b3a7a
FDA-2001-P-0156-0001 FDA Request to file an ANDA for Ifosfamide for Injection FDA-2001-P-0156 FDA/DDM to Tom Stothoff Other ACK-Acknowledgement Letter 2001-02-02T05:00:00Z 2001 2     2008-04-25T02:25:53Z   0 0 09000064804df23f
FDA-2000-D-0598-0005 FDA Genotoxicity Studies (VICH GL23) FDA-2000-D-0598 FDA GeneTox Network to Dockets Management - Memorandum Other Memorandum 2001-01-23T05:00:00Z 2001 1 2013-01-23T05:00:00Z   2013-01-23T19:10:07Z   0 0 09000064804dd8b3

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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);