Application 203269
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | TABLET;ORAL | EQ 5MG BASE | No | No |
| 002 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | TABLET;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-3343 | Rizatriptan Benzoate | Rizatriptan Benzoate | A-S Medication Solutions | ANDA | Current |
| 50090-3343 | Rizatriptan Benzoate | Rizatriptan Benzoate | A-S Medication Solutions | ANDA | Current |
| 53002-3713 | Rizatriptan Benzoate | Rizatriptan Benzoate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 63629-8122 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8122 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 67877-261 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-261 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-261 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-261 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-262 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-262 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-262 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 67877-262 | Rizatriptan Benzoate | Rizatriptan Benzoate | Ascend Laboratories, LLC | ANDA | Current |
| 71335-1283 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1283 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1283 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1577 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1577 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 71335-2031 | Rizatriptan Benzoate | Rizatriptan Benzoate | Bryant Ranch Prepack | ANDA | Current |
| 72189-316 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | Direct Rx | ANDA | Current |