Data as of 2026-07-12 — 788,886 rows loaded

022021

NDA KING PFIZER
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 ALTACE RAMIPRIL TABLET;ORAL 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
002 ALTACE RAMIPRIL TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
003 ALTACE RAMIPRIL TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
004 ALTACE RAMIPRIL TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Discontinued ✓
Submissions
Type#StatusDate ClassReview PriorityNotes
SUPPL 8 AP 2012-01-18 LABELING STANDARD
SUPPL 7 AP 2011-08-04 LABELING STANDARD
SUPPL 6 AP 2009-11-20 LABELING STANDARD
SUPPL 1 AP 2009-03-04 LABELING STANDARD
SUPPL 5 AP 2009-02-09 LABELING STANDARD
ORIG 1 AP 2007-02-27 TYPE 3 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2012-01-23 Letter SUPPL-8 0
2012-01-23 Label SUPPL-8 0
2011-08-12 Label SUPPL-7 0
2011-08-08 Letter SUPPL-7 0
2010-01-20 Letter SUPPL-6 0
2009-11-23 Label SUPPL-6 0
2009-03-06 Letter SUPPL-1 0
2009-02-18 Letter SUPPL-5 0
2008-07-01 Other Important Information from FDA ORIG-1 0
2008-03-14 Review ORIG-1 0
2007-03-07 Letter ORIG-1 0
2007-03-07 Label ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "1", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "7", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "8", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "6", "ActionTypes_LookupID": "13"}
2026-07-12 join_submission_action_types INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "5", "ActionTypes_LookupID": "13"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "8", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "7", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "6", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "5", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 submission_property_type INSERT {"ApplNo": "022021", "SubmissionType": "ORIG", "SubmissionNo": "1", "SubmissionPropertyTypeCode": "Null"}
2026-07-12 marketing_status INSERT {"ApplNo": "022021", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "022021", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "022021", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "022021", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "8"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "7"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "6"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "5"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "SUPPL", "SubmissionNo": "1"}
2026-07-12 submissions INSERT {"ApplNo": "022021", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "022021", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "022021", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "022021", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "022021", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "022021"}