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 |
| 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 |