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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

44 rows where docket_id = "FDA-1994-P-0028" and posted_year = 2017 sorted by posted_date descending

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  • 2017 · 44 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-1994-P-0028-0047 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T16:45:07Z   0 0 09000064804fd363
FDA-1994-P-0028-0046 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab G: Letter from Geneva Pharmaceuticals to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2017-12-29T16:44:36Z   0 0 09000064804fd353
FDA-1994-P-0028-0045 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Citizen Petition Denial Response Letter from FDA ORA to Mckenna & Cuneo Other Denial of Petition 2017-10-05T04:00:00Z 2017 10 2017-10-05T04:00:00Z   2017-10-05T13:53:52Z   0 0 09000064804fd37c
FDA-1994-P-0028-0021 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 1: Letter from FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:21:40Z   0 0 09000064804fd355
FDA-1994-P-0028-0035 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab F: U. S. District Court for the District of Colorado Marion Merrell Dow, Inc v. Geneva Pharmaceuticals, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:57:17Z   0 0 09000064804fd36c
FDA-1994-P-0028-0028 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 1: Citizen Petition from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:31:00Z   0 0 09000064804fd36a
FDA-1994-P-0028-0038 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:18:01Z   0 0 09000064804fd360
FDA-1994-P-0028-0023 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 3: U. S. District Court for District of New Jersey Barr Lab vs Otis Bowen et al, re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T16:07:24Z   0 0 09000064804fd357
FDA-1994-P-0028-0032 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab C: FDA Approved Drug Products with Therapeutic Equivalence Evaluations (13th Ed and 6th Ed) re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:45:33Z   0 0 09000064804fd366
FDA-1994-P-0028-0031 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab B: FDA Approved Drug Products with Therapeutic Equivalence Evaluations 11th Edition re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:41:44Z   0 0 09000064804fd367
FDA-1994-P-0028-0029 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 2: U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc vs. USA re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:35:38Z   0 0 09000064804fd369
FDA-1994-P-0028-0022 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:23:40Z   0 0 09000064804fd356
FDA-1994-P-0028-0027 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Other Petition for Reconsideration 2017-10-04T04:00:00Z 2017 10 1994-07-12T04:00:00Z   2017-10-04T18:25:17Z   0 0 09000064804fd36b
FDA-1994-P-0028-0033 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab D: Letter From Geneva Pharmaceuticals, Inc. To FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:48:35Z   0 0 09000064804fd365
FDA-1994-P-0028-0042 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 4 U. S. District Court for District Columbia Geneva Pharmaceuticals Inc, v USA re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:38:48Z   0 0 09000064804fd35b
FDA-1994-P-0028-0024 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:28:40Z   0 0 09000064804fd358
FDA-1994-P-0028-0015 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab C: FDA Approved Drug Products with Therapeutic Equivalence Evaluations (13th Ed and 6th Ed) re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:09:10Z   0 0 09000064804fd34a
FDA-1994-P-0028-0037 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 1: Letter from FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:15:48Z   0 0 09000064804fd361
FDA-1994-P-0028-0040 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:28:48Z   0 0 09000064804fd35d
FDA-1994-P-0028-0039 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 3: U. S. District Court District of New Jersey Barr Lab v. Otis Bowen, et. al., re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:22:09Z   0 0 09000064804fd35f
FDA-1994-P-0028-0036 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab H: Letter from FDA OGC to McKenna & Cuneo re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:05:14Z   0 0 09000064804fd362
FDA-1994-P-0028-0012 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 1: U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc. v. USA re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T16:03:18Z   0 0 09000064804fd342
FDA-1994-P-0028-0025 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 2 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:52:05Z   0 0 0900006482b9ba01
FDA-1994-P-0028-0030 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab A: Letter from Geneva Pharmaceuticals to FDA CDER re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:38:39Z   0 0 09000064804fd368
FDA-1994-P-0028-0017 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab E: Letter from Geneva Pharmaceuticals, Inc. to Marion Merrell Dow re Correction from Geneva Pharmaceuticals, Inc. ( McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:08:55Z   0 0 09000064804fd34f
FDA-1994-P-0028-0018 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab 2: U. S. District Court D.C. Geneva Pharmaceuticals vs. USA re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:47:18Z   0 0 09000064804fd351
FDA-1994-P-0028-0034 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab E: Letter from Geneva Pharmaceuticals to Marion Merrell Dow re: Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T18:52:25Z   0 0 09000064804fd364
FDA-1994-P-0028-0013 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab A: Letter from Geneva Pharmaceuticals, Inc. to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:09:27Z   0 0 09000064804fd345
FDA-1994-P-0028-0026 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 3: U. S. District Court for District of Columbia Geneva Pharmaceuticals, Inc. vs. USA re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:55:36Z   0 0 09000064804fd35a
FDA-1994-P-0028-0014 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab B: FDA Approved Drug Products with Therapeutic Equivalence (11th Edition) re Correction from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:09:18Z   0 0 09000064804fd347
FDA-1994-P-0028-0016 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab D: Letter from Geneva Pharmaceuticals, Inc. to FDA CDER re Correction from Geneva Pharmaceuticals, Inc. ( McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:09:02Z   0 0 09000064804fd34c
FDA-1994-P-0028-0019 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab F: U. S. District Court for District of Columbia Marion Merrell Dow, Inc. vs Geneva Pharmaceuticals, Inc. re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T16:13:00Z   0 0 09000064804fd352
FDA-1994-P-0028-0041 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 3 U. S. District Court for District of Columbia Geneva Pharmaceuticals Inc, V. United States of America re : Petition for Stay of Action from Geneva Pharmaceuticals, Inc. (McKenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T19:34:20Z   0 0 09000064804fd35c
FDA-1994-P-0028-0020 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Tab H: Letter from FDA OCG to McKenna & Cuneo re Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-10-04T04:00:00Z 2017 10     2017-10-04T15:18:40Z   0 0 09000064804fd354
FDA-1994-P-0028-0007 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 4: Letter from FDA CDER to Vitarine Pharmaceuticals, Inc. re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-10-04T16:09:13Z   0 0 0900006482a1e114
FDA-1994-P-0028-0010 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Acknowledgment Letter from FDA DDM to McKenna & Cuneo Other Acknowledgement Letter/Receipt 2017-09-29T04:00:00Z 2017 9 2017-09-29T04:00:00Z   2017-09-29T18:29:46Z   0 0 09000064804fd37e
FDA-1994-P-0028-0011 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Correction from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Other Correction(s) 2017-09-29T04:00:00Z 2017 9 1994-07-12T04:00:00Z   2017-10-04T14:39:08Z   0 0 09000064804fd359
FDA-1994-P-0028-0005 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 2: Letter from FDA CDER to American Therapeutics, Inc. re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-10-04T16:06:35Z   0 0 0900006482a1d907
FDA-1994-P-0028-0004 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 1: Letter from FDA CDER re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-10-04T16:05:39Z   0 0 0900006482a1cef1
FDA-1994-P-0028-0008 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 2 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-09-29T18:22:27Z   0 0 0900006482a1def0
FDA-1994-P-0028-0009 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 3 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-09-29T18:27:11Z   0 0 0900006482a1e043
FDA-1994-P-0028-0003 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Attachment 1 U. S. District Court for District of Columbia Geneva Pharmaceutical, Inc. vs USA re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-09-29T18:00:13Z   0 0 0900006482a1c493
FDA-1994-P-0028-0006 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Exhibit 3: U. S. District Court of New Jersey Barr Lab Inc. v. Otis Bowen et al., re Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Supporting & Related Material Background Material 2017-09-29T04:00:00Z 2017 9     2017-10-04T15:46:14Z   0 0 0900006482a1d6d2
FDA-1994-P-0028-0002 FDA Acknowledge Geneva's Right to 180 days of Market Exclusivity Terfenadine-CLOSED FDA-1994-P-0028 Citizen Petition from Geneva Pharmaceuticals, Inc. (Mckenna & Cuneo) Other Citizen Petition 2017-09-22T04:00:00Z 2017 9 1994-07-08T04:00:00Z   2017-10-06T01:04:22Z   0 0 09000064804fd340

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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);