Application 078056
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
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 |
|---|---|---|---|---|---|
| 0228-3083 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3083 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3083 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3083 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3084 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3084 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3084 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3084 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3086 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3086 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3086 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3086 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3087 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3087 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3087 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-3087 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 63629-5364 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 63629-5364 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 68788-6943 | Alprazolam | Alprazolam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6943 | Alprazolam | Alprazolam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6943 | Alprazolam | Alprazolam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-0427 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0427 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1129 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1129 | Alprazolam | Alprazolam | Bryant Ranch Prepack | ANDA | Current |