Application 078561
- Type
- ANDA
- Sponsor
- ACTAVIS ELIZABETH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALPRAZOLAM | ALPRAZOLAM | TABLET, ORALLY DISINTEGRATING;ORAL | 0.25MG | No | No |
| 002 | ALPRAZOLAM | ALPRAZOLAM | TABLET, ORALLY DISINTEGRATING;ORAL | 0.5MG | No | No |
| 003 | ALPRAZOLAM | ALPRAZOLAM | TABLET, ORALLY DISINTEGRATING;ORAL | 1MG | No | No |
| 004 | ALPRAZOLAM | ALPRAZOLAM | TABLET, ORALLY DISINTEGRATING;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4019 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4022 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4024 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |
| 0228-4025 | Alprazolam | Alprazolam | Actavis Pharma, Inc. | ANDA | Current |