Application 077950
- 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 | SOLUTION;ORAL | EQ 20MG BASE/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 64980-405 | Abacavir | Abacavir Sulfate | Rising Pharmaceuticals, Inc. | ANDA | Current |
| 65862-089 | Abacavir | Abacavir Sulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-089 | Abacavir | Abacavir Sulfate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-089 | Abacavir | Abacavir Sulfate | Aurobindo Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31310 | ORIG | 2006-07-03 |