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56 rows where docket_id = "FDA-2019-P-3192" sorted by posted_date descending

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document_type 2

  • Supporting & Related Material 51
  • Other 5

posted_year 1

  • 2019 56

agency_id 1

  • FDA 56
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2019-P-3192-0044 FDA None FDA-2019-P-3192 Exhibit 13 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:49:02Z   0 0 09000064842534a6
FDA-2019-P-3192-0047 FDA None FDA-2019-P-3192 Exhibit 16 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:50:24Z   0 0 09000064842534a9
FDA-2019-P-3192-0052 FDA None FDA-2019-P-3192 Exhibit 21 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:52:05Z   0 0 09000064842534ae
FDA-2019-P-3192-0037 FDA None FDA-2019-P-3192 Exhibit 6 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:42:42Z   0 0 0900006484253492
FDA-2019-P-3192-0051 FDA None FDA-2019-P-3192 Exhibit 20 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:51:40Z   0 0 09000064842534ad
FDA-2019-P-3192-0042 FDA None FDA-2019-P-3192 Exhibit 11 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:45:08Z   0 0 0900006484253497
FDA-2019-P-3192-0038 FDA None FDA-2019-P-3192 Exhibit 7 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:43:03Z   0 0 0900006484253493
FDA-2019-P-3192-0032 FDA None FDA-2019-P-3192 Exhibit 1 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:36:46Z   0 0 0900006484251530
FDA-2019-P-3192-0043 FDA None FDA-2019-P-3192 Exhibit 12 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:48:44Z   0 0 09000064842534a5
FDA-2019-P-3192-0057 FDA None FDA-2019-P-3192 Exhibit 26 Virazole - ribavirin powder, for solution re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:58:04Z   0 0 0900006484253862
FDA-2019-P-3192-0039 FDA None FDA-2019-P-3192 Exhibit 8 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:43:30Z   0 0 0900006484253494
FDA-2019-P-3192-0034 FDA None FDA-2019-P-3192 Exhibit 3 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:41:17Z   0 0 090000648425348f
FDA-2019-P-3192-0045 FDA None FDA-2019-P-3192 Exhibit 14 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:49:27Z   0 0 09000064842534a7
FDA-2019-P-3192-0033 FDA None FDA-2019-P-3192 Exhibit 2 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:40:57Z   0 0 090000648425348e
FDA-2019-P-3192-0036 FDA None FDA-2019-P-3192 Exhibit 5 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:42:25Z   0 0 0900006484253491
FDA-2019-P-3192-0048 FDA None FDA-2019-P-3192 Exhibit 17 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:50:43Z   0 0 09000064842534aa
FDA-2019-P-3192-0053 FDA None FDA-2019-P-3192 Exhibit 22 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:52:27Z   0 0 090000648425385e
FDA-2019-P-3192-0035 FDA None FDA-2019-P-3192 Exhibit 4 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:41:55Z   0 0 0900006484253490
FDA-2019-P-3192-0031 FDA None FDA-2019-P-3192 Acknowledgment Letter from FDA DMS to US WorldMeds, LLC Other Acknowledgement Letter/Receipt 2019-12-27T05:00:00Z 2019 12 2019-12-27T05:00:00Z   2020-04-14T21:58:12Z   0 0 0900006484251cf0
FDA-2019-P-3192-0040 FDA None FDA-2019-P-3192 Exhibit 9 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:44:06Z   0 0 0900006484253495
FDA-2019-P-3192-0046 FDA None FDA-2019-P-3192 Exhibit 15 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:50:08Z   0 0 09000064842534a8
FDA-2019-P-3192-0049 FDA None FDA-2019-P-3192 Exhibit 18 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:50:57Z   0 0 09000064842534ab
FDA-2019-P-3192-0050 FDA None FDA-2019-P-3192 Exhibit 19 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:51:16Z   0 0 09000064842534ac
FDA-2019-P-3192-0055 FDA None FDA-2019-P-3192 Exhibit 24 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:53:00Z   0 0 0900006484253860
FDA-2019-P-3192-0056 FDA None FDA-2019-P-3192 Exhibit 25 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:53:41Z   0 0 0900006484253861
FDA-2019-P-3192-0054 FDA None FDA-2019-P-3192 Exhibit 23 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:52:44Z   0 0 090000648425385f
FDA-2019-P-3192-0041 FDA None FDA-2019-P-3192 Exhibit 10 re Petition for Reconsideration from US WorldMeds, LLC Supporting & Related Material Background Material 2019-12-27T05:00:00Z 2019 12     2019-12-27T18:44:44Z   0 0 0900006484253496
FDA-2019-P-3192-0030 FDA None FDA-2019-P-3192 Citizen Petition from US WorldMeds, LLC Other Citizen Petition 2019-12-27T05:00:00Z 2019 12 2019-12-27T05:00:00Z   2020-04-14T21:56:20Z   0 0 0900006484251cef
FDA-2019-P-3192-0029 FDA None FDA-2019-P-3192 Letter from FDA CDER to US WorldMeds Other Letter(s) 2019-11-27T05:00:00Z 2019 11 2019-11-27T05:00:00Z   2019-11-27T16:39:49Z   0 0 09000064841c0c56
FDA-2019-P-3192-0009 FDA None FDA-2019-P-3192 Exhibit 7- APOKYN Apomorphine Hydrochloride Injection re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:50Z   0 0 0900006483d570cb
FDA-2019-P-3192-0013 FDA None FDA-2019-P-3192 Exhibit 11- Patients’ and caregivers’ experiences of the impact of Parkinson’s disease on health status re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:32Z   0 0 0900006483d5794c
FDA-2019-P-3192-0007 FDA None FDA-2019-P-3192 Exhibit 5- Parkinson's Disease and Movement Disorders: Moving Forward re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:38Z   0 0 0900006483d57254
FDA-2019-P-3192-0021 FDA None FDA-2019-P-3192 Exhibit 19- Center for Drug Evaluation and Research: Summary Review re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:31Z   0 0 0900006483d57697
FDA-2019-P-3192-0026 FDA None FDA-2019-P-3192 Exhibit 24- Injection Safety re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:29:06Z   0 0 0900006483d577cb
FDA-2019-P-3192-0025 FDA None FDA-2019-P-3192 Exhibit 23- Sharing Insulin Pens: Are You Putting Patients at Risk re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:29:00Z   0 0 0900006483d577ca
FDA-2019-P-3192-0006 FDA None FDA-2019-P-3192 Exhibit 4- Past, Present, and Future of Parkinson's Disease: A Special Essay on the 200th Anniversary of the Shaking Palsy re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:31Z   0 0 0900006483d57222
FDA-2019-P-3192-0020 FDA None FDA-2019-P-3192 Exhibit 18- Center for Drug Evaluation and Research: Other Action Letters re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:24Z   0 0 0900006483d57696
FDA-2019-P-3192-0016 FDA None FDA-2019-P-3192 Exhibit 14- About APOKYN re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:53Z   0 0 0900006483d5794f
FDA-2019-P-3192-0012 FDA None FDA-2019-P-3192 Exhibit 10- Non- Motor Features of Parkinson Disease re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:17Z   0 0 0900006483d570dd
FDA-2019-P-3192-0010 FDA None FDA-2019-P-3192 Exhibit 8- The Voice of the Patient re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:58Z   0 0 0900006483d570cc
FDA-2019-P-3192-0023 FDA None FDA-2019-P-3192 Exhibit 21- Complete Response re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:48Z   0 0 0900006483d57699
FDA-2019-P-3192-0001 FDA None FDA-2019-P-3192 Citizen Petition from US WorldMeds Other Citizen Petition 2019-07-03T04:00:00Z 2019 7 2019-07-03T04:00:00Z   2020-04-15T20:22:32Z   0 0 0900006483d56c7d
FDA-2019-P-3192-0018 FDA None FDA-2019-P-3192 Exhibit 16- Starting APOKYN re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:07Z   0 0 0900006483d57979
FDA-2019-P-3192-0004 FDA None FDA-2019-P-3192 Exhibit 2- Cognitive Decline in Parkinson Disease re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:16Z   0 0 0900006483d57220
FDA-2019-P-3192-0027 FDA None FDA-2019-P-3192 Exhibit 25- FDA in Brief: To advance efficient development and review of combination products, the FDA outlines principles to promote a more predictable premarket review pathway re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:29:14Z   0 0 0900006483d577cc
FDA-2019-P-3192-0015 FDA None FDA-2019-P-3192 Exhibit 13- Early Detection of Wearing off in Parkinson disease: The DEEP study re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:45Z   0 0 0900006483d5794e
FDA-2019-P-3192-0008 FDA None FDA-2019-P-3192 Exhibit 6- Continued Efficacy and Safety of Subcutaneous Apomorphine Inpatients with Advanced Parkinson’s Disease re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:44Z   0 0 0900006483d570ca
FDA-2019-P-3192-0003 FDA None FDA-2019-P-3192 Exhibit 1- Highlights of Prescribing Information re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:09Z   0 0 0900006483d5721f
FDA-2019-P-3192-0019 FDA None FDA-2019-P-3192 Exhibit 17- Highlights of Prescribing Information re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:17Z   0 0 0900006483d5797a
FDA-2019-P-3192-0002 FDA None FDA-2019-P-3192 Acknowledgment Letter from FDA DDM to US WorldMeds Other Acknowledgement Letter/Receipt 2019-07-03T04:00:00Z 2019 7 2019-07-03T04:00:00Z   2019-07-03T14:26:00Z   0 0 0900006483d56f0c
FDA-2019-P-3192-0022 FDA None FDA-2019-P-3192 Exhibit 20- 2018 AMA Prior Authorization (PA) Physician Survey re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:38Z   0 0 0900006483d57698
FDA-2019-P-3192-0017 FDA None FDA-2019-P-3192 Exhibit 15- APOKYN Pen Instructions for Use re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:01Z   0 0 0900006483d57950
FDA-2019-P-3192-0014 FDA None FDA-2019-P-3192 Exhibit 12- Impact of the Motor Complications of Parkinson’s Disease on the Quality of Life re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:38Z   0 0 0900006483d5794d
FDA-2019-P-3192-0005 FDA None FDA-2019-P-3192 Exhibit 3- Parkinson's Disease: Hope Through Research re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:26:23Z   0 0 0900006483d57221
FDA-2019-P-3192-0011 FDA None FDA-2019-P-3192 Exhibit 9- Managing PD Mid- Stride re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:27:10Z   0 0 0900006483d570cd
FDA-2019-P-3192-0024 FDA None FDA-2019-P-3192 Exhibit 22- Ongoing Role of FDA in Medication Error Prevention re Citizen Petition from US WorldMeds Supporting & Related Material Background Material 2019-07-03T04:00:00Z 2019 7     2019-07-03T14:28:54Z   0 0 0900006483d5773d

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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;
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