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56 rows where docket_id = "FDA-2019-P-3192" sorted by posted_date descending
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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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-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;