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Application 078119
- Type
- ANDA
- Sponsor
- CIPLA
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 |
|---|
| 69097-514 | Abacavir | Abacavir | Cipla USA Inc. | ANDA | Current |
| 69097-514 | Abacavir | Abacavir | Cipla USA Inc. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-1274 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31333 | ORIG | 2006-11-07 |