Application 091560
- Type
- ANDA
- Sponsor
- HETERO LABS LTD III
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABACAVIR SULFATE | ABACAVIR SULFATE | TABLET;ORAL | EQ 300MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 31722-557 | Abacavir | Abacavir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-557 | Abacavir | Abacavir | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 50268-049 | Abacavir | Abacavir | AvPAK | ANDA | Current |
| 50268-049 | Abacavir | Abacavir | AvPAK | ANDA | Current |
| 50268-049 | Abacavir | Abacavir | AvPAK | ANDA | Current |
| 72865-167 | Abacavir | Abacavir | XLCare Pharmaceuticals Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9342 | ORIG | 2010-10-04 |