Application 021387
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,20MG | No | No |
| 002 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,40MG | No | No |
| 003 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET, TABLET;ORAL | 81MG,N/A;N/A,80MG | No | No |
| 004 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET, TABLET;ORAL | 325MG,N/A;N/A,20MG | No | No |
| 005 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET, TABLET;ORAL | 325MG,N/A;N/A,40MG | No | No |
| 006 | PRAVIGARD PAC (COPACKAGED) | ASPIRIN; PRAVASTATIN SODIUM | TABLET, TABLET;ORAL | 325MG,N/A;N/A,80MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 21629 | ORIG | 2004-01-29 |
| 36806 | ORIG | 2003-07-08 |
| 5236 | ORIG | 2003-07-06 |