Application 020412
- Type
- NDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZERIT | STAVUDINE | CAPSULE;ORAL | 5MG | No | No |
| 002 | ZERIT | STAVUDINE | CAPSULE;ORAL | 15MG | Yes | No |
| 003 | ZERIT | STAVUDINE | CAPSULE;ORAL | 20MG | Yes | No |
| 004 | ZERIT | STAVUDINE | CAPSULE;ORAL | 30MG | Yes | No |
| 005 | ZERIT | STAVUDINE | CAPSULE;ORAL | 40MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0003-1964 | ZERIT | Stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1965 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1965 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1965 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1966 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1966 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1966 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1967 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1967 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 0003-1967 | ZERIT | stavudine | E.R. Squibb & Sons, L.L.C. | NDA | Current |
| 53808-0656 | ZERIT | stavudine | State of Florida DOH Central Pharmacy | NDA | Current |
| 53808-0657 | ZERIT | stavudine | State of Florida DOH Central Pharmacy | NDA | Current |
| 53808-0795 | ZERIT | stavudine | State of Florida DOH Central Pharmacy | NDA | Current |