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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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