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

021387

NDA BRISTOL MYERS SQUIBB
Products
#Drug NameActive Ingredient FormStrengthMarketing StatusTE Codes Ref DrugRef Std
001 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 81MG;20MG Discontinued
002 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 81MG;40MG Discontinued
003 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 81MG;80MG Discontinued
004 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 325MG;20MG Discontinued
005 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 325MG;40MG Discontinued
006 PRAVIGARD PAC (COPACKAGED) ASPIRIN; PRAVASTATIN SODIUM TABLET;ORAL 325MG;80MG Discontinued
Submissions
Type#StatusDate ClassReview PriorityNotes
ORIG 1 AP 2003-06-24 TYPE 4 STANDARD
Documents (latest 100)
DateTypeSubmissionTitle / Link
2004-01-29 Review ORIG-1 0
2003-07-08 Label ORIG-1 0
2003-07-06 Letter ORIG-1 0
Change History (all loads)
DateTableChangeKey
2026-07-12 join_submission_action_types INSERT {"ApplNo": "021387", "SubmissionType": "ORIG", "SubmissionNo": "1", "ActionTypes_LookupID": "46"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "006"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "005"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "004"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "003"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "002"}
2026-07-12 marketing_status INSERT {"ApplNo": "021387", "ProductNo": "001"}
2026-07-12 submissions INSERT {"ApplNo": "021387", "SubmissionType": "ORIG", "SubmissionNo": "1"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "006"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "005"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "004"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "003"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "002"}
2026-07-12 products INSERT {"ApplNo": "021387", "ProductNo": "001"}
2026-07-12 applications INSERT {"ApplNo": "021387"}