Application 090871
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ALPRAZOLAM | ALPRAZOLAM | TABLET, EXTENDED RELEASE;ORAL | 0.5MG | No | No |
| 002 | ALPRAZOLAM | ALPRAZOLAM | TABLET, EXTENDED RELEASE;ORAL | 1MG | No | No |
| 003 | ALPRAZOLAM | ALPRAZOLAM | TABLET, EXTENDED RELEASE;ORAL | 2MG | No | No |
| 004 | ALPRAZOLAM | ALPRAZOLAM | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 45865-653 | Alprazolam | Alprazolam | Medsource Pharmaceuticals | ANDA | Current |
| 52959-964 | ALPRAZOLAM | ALPRAZOLAM | H.J. Harkins Company, Inc. | ANDA | Current |
| 63187-445 | Alprazolam | Alprazolam | Proficient Rx LP | ANDA | Current |
| 63187-445 | Alprazolam | Alprazolam | Proficient Rx LP | ANDA | Current |
| 63187-518 | Alprazolam | Alprazolam | Proficient Rx LP | ANDA | Current |
| 63187-518 | Alprazolam | Alprazolam | Proficient Rx LP | ANDA | Current |
| 65862-454 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-454 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-454 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-454 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-454 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-455 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-455 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-455 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-455 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-455 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-456 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-456 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-456 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-456 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-456 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-457 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-457 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-457 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-457 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 65862-457 | Alprazolam | Alprazolam | Aurobindo Pharma Limited | ANDA | Current |
| 68788-9682 | Alprazolam | Alprazolam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9682 | Alprazolam | Alprazolam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9682 | Alprazolam | Alprazolam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9682 | Alprazolam | Alprazolam | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-2870 | Alprazolam | Alprazolam | REMEDYREPACK INC. | ANDA | Current |
| 70518-2870 | Alprazolam | Alprazolam | REMEDYREPACK INC. | ANDA | Current |
| 71335-1669 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1669 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1669 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1839 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1839 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 72189-029 | ALPRAZOLAM | ALPRAZOLAM | Direct_Rx | ANDA | Current |
| 72189-029 | ALPRAZOLAM | ALPRAZOLAM | Direct_Rx | ANDA | Current |
| 72189-029 | ALPRAZOLAM | ALPRAZOLAM | Direct_Rx | ANDA | Current |