Application 090092
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIDOVUDINE | ZIDOVUDINE | TABLET;ORAL | 300MG | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-509 | Zidovudine | Zidovudine | Camber Pharmaceuticals | ANDA | Current |
| 31722-509 | Zidovudine | Zidovudine | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1656 | Zidovudine | Zidovudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1656 | Zidovudine | Zidovudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1656 | Zidovudine | Zidovudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1656 | Zidovudine | Zidovudine | REMEDYREPACK INC. | ANDA | Current |
| 70518-1656 | Zidovudine | Zidovudine | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9256 | ORIG | 2008-04-28 |