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withdrawn,object_id FDA-2021-P-0923-0005,FDA,FDA-2021-P-0923,Agency Response Letter from FDA CDER to Gland Pharma Limited,Other,Agency Response,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T20:33:10Z,,0,0,0900006484ee7299 FDA-2021-P-0923-0004,FDA,FDA-2021-P-0923,"Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness",Notice,Determinations,2021-12-22T05:00:00Z,2021,12,2021-12-22T05:00:00Z,,2021-12-22T13:22:01Z,2021-27699,0,0,0900006484ee09d0 FDA-2021-P-0923-0003,FDA,FDA-2021-P-0923,Attachment - I current orange book status re Citizen Petition from Gland Pharma Limited,Supporting & Related Material,Background Material,2021-08-20T04:00:00Z,2021,8,,,2021-08-20T12:57:54Z,,0,0,0900006484c8d400 FDA-2021-P-0923-0002,FDA,FDA-2021-P-0923,Acknowledgment Letter from FDA DMS to Gland Pharma Limited,Other,Acknowledgement Letter/Receipt,2021-08-20T04:00:00Z,2021,8,2021-08-20T04:00:00Z,,2021-08-20T12:57:49Z,,0,0,0900006484c8cb24 FDA-2021-P-0923-0001,FDA,FDA-2021-P-0923,Citizen Petition from Gland Pharma Limited,Other,Citizen Petition,2021-08-20T04:00:00Z,2021,8,2021-08-20T04:00:00Z,,2021-12-22T20:33:27Z,,0,0,0900006484c8d3fe