Application 078957
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-515 | Stavudine | Stavudine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-516 | Stavudine | Stavudine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-517 | Stavudine | Stavudine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-518 | Stavudine | Stavudine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 53808-0595 | Stavudine | Stavudine | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9204 | ORIG | 2008-12-31 |
| 9203 | ORIG | 2008-03-04 |