Application 079069
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | STAVUDINE | STAVUDINE | CAPSULE;ORAL | 15MG | No | No |
| 002 | STAVUDINE | STAVUDINE | CAPSULE;ORAL | 20MG | No | No |
| 003 | STAVUDINE | STAVUDINE | CAPSULE;ORAL | 30MG | No | No |
| 004 | STAVUDINE | STAVUDINE | CAPSULE;ORAL | 40MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 53808-0594 | Stavudine | Stavudine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-0852 | Stavudine | stavudine | State of Florida DOH Central Pharmacy | ANDA | Current |