Application 078173
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 5MG BASE | No | No |
| 002 | RIZATRIPTAN BENZOATE | RIZATRIPTAN BENZOATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-3701 | Rizatriptan Benzoate | rizatriptan benzoate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3701 | Rizatriptan Benzoate | rizatriptan benzoate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3702 | Rizatriptan Benzoate | rizatriptan benzoate | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-3702 | Rizatriptan Benzoate | rizatriptan benzoate | Mylan Pharmaceuticals Inc. | ANDA | Current |