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withdrawn,object_id FDA-2022-P-0614-0007,FDA,FDA-2022-P-0614,"Response Letter from FDA CDER to Yichang Humanwell Pharmaceuticals, LLC",Other,Response(s),2022-12-21T05:00:00Z,2022,12,2022-12-21T05:00:00Z,,2022-12-21T18:21:19Z,,0,0,0900006485549f61 FDA-2022-P-0614-0006,FDA,FDA-2022-P-0614,"Determination That ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2022-12-21T05:00:00Z,2022,12,2022-12-21T05:00:00Z,,2022-12-21T15:58:45Z,2022-27647,0,0,0900006485548d58 FDA-2022-P-0614-0005,FDA,FDA-2022-P-0614,Interim Response Letter from FDA CDER to Yichang Humanwell Pharmaceuticals LLC,Other,Letter(s),2022-10-26T04:00:00Z,2022,10,2022-10-26T04:00:00Z,,2022-10-26T12:25:39Z,,0,0,090000648545ccbf FDA-2022-P-0614-0004,FDA,FDA-2022-P-0614,Attachment 2 - Cumulative Supplement of the Orange Book - July 2019 - re: Citizen Petition from Yichang Humanwell Pharmaceutical Co. Ltd.,Supporting & Related Material,Background Material,2022-04-19T04:00:00Z,2022,4,,,2022-04-19T17:43:37Z,,0,0,0900006485023c43 FDA-2022-P-0614-0002,FDA,FDA-2022-P-0614,Acknowledgment Letter from FDA DMS to Yichang Humanwell Pharmaceutical Co. Ltd.,Other,Acknowledgement Letter/Receipt,2022-04-19T04:00:00Z,2022,4,2022-04-19T04:00:00Z,,2022-04-19T17:43:20Z,,0,0,0900006485023f43 FDA-2022-P-0614-0001,FDA,FDA-2022-P-0614,"Citizen Petition from Yichang Humanwell Pharmaceutical Co., Ltd.",Other,Citizen Petition,2022-04-19T04:00:00Z,2022,4,2022-04-19T04:00:00Z,,2022-12-21T17:09:54Z,,0,0,0900006485023ad5 FDA-2022-P-0614-0003,FDA,FDA-2022-P-0614,Attachment 1- Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations - re: Citizen Petition from Yichang Humanwell Pharmaceutical Co. Ltd.,Supporting & Related Material,Background Material,2022-04-19T04:00:00Z,2022,4,,,2022-04-19T17:43:30Z,,0,0,0900006485023c3c