Application 078491
- Type
- ANDA
- Sponsor
- OXFORD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 0.25MG | No | No |
| 002 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 0.5MG | No | No |
| 003 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 1MG | No | No |
| 004 | ALPRAZOLAM | ALPRAZOLAM | TABLET;ORAL | 2MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45865-424 | Alprazolam | alprazolam | Medsource Pharmaceuticals | ANDA | Current |
| 61919-006 | ALPRAZOLAM | ALPRAZOLAM | DIRECT RX | ANDA | Current |
| 61919-379 | ALPRAZOLAM | ALPRAZOLAM | DIRECT RX | ANDA | Current |
| 61919-379 | ALPRAZOLAM | ALPRAZOLAM | Direct_Rx | ANDA | Current |
| 61919-447 | ALPRAZOLAM | ALPRAZOLAM | DIRECT RX | ANDA | Current |
| 61919-447 | ALPRAZOLAM | ALPRAZOLAM | DIRECT RX | ANDA | Current |
| 66336-932 | Alprazolam | alprazolam | Dispensing Solutions, Inc. | ANDA | Current |