Application 021453
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZERIT XR | STAVUDINE | CAPSULE, EXTENDED RELEASE;ORAL | 37.5MG | No | No |
| 002 | ZERIT XR | STAVUDINE | CAPSULE, EXTENDED RELEASE;ORAL | 50MG | No | No |
| 003 | ZERIT XR | STAVUDINE | CAPSULE, EXTENDED RELEASE;ORAL | 75MG | No | No |
| 004 | ZERIT XR | STAVUDINE | CAPSULE, EXTENDED RELEASE;ORAL | 100MG | No | No |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 21670 | ORIG | 2006-06-08 |
| 36978 | SUPPL | 2005-01-21 |
| 27835 | SUPPL | 2005-01-21 |
| 36977 | SUPPL | 2004-06-07 |
| 5432 | SUPPL | 2004-06-07 |
| 36976 | ORIG | 2003-04-09 |
| 5431 | ORIG | 2002-12-31 |