Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021387
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 81MG;20MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 81MG;40MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 81MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 325MG;20MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 325MG;40MG | TABLET;ORAL | Discontinued | None | No | No |
PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | 325MG;80MG | TABLET;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/24/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21387_pravigard_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21387ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-387_Pravagard.cfm |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/24/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21387_pravigard_lbl.pdf |