Application 077844
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
|---|
| 0904-6874 | Abacavir | Abacavir | Major Pharmaceuticals | ANDA | Current |
| 0904-6874 | Abacavir | Abacavir | Major Pharmaceuticals | ANDA | Current |
| 0904-6874 | Abacavir | Abacavir | Major Pharmaceuticals | ANDA | Current |
| 65862-073 | Abacavir | Abacavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-073 | Abacavir | Abacavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-073 | Abacavir | Abacavir | Aurobindo Pharma Limited | ANDA | Current |
| 65862-073 | Abacavir | Abacavir | Aurobindo Pharma Limited | ANDA | Current |
| 68084-021 | Abacavir | Abacavir Sulfate | American Health Packaging | ANDA | Current |
| 68084-021 | Abacavir | Abacavir Sulfate | American Health Packaging | ANDA | Current |
| 68084-021 | Abacavir | Abacavir | American Health Packaging | ANDA | Current |
| 70518-0559 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
| 70518-0559 | Abacavir | Abacavir | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9089 | ORIG | 2006-05-21 |