Application 203146
- Type
- ANDA
- Sponsor
- MACLEODS PHARMS LTD
Application Products#
Product, Drug, Ingredient table| 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 table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 33342-093 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-093 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-093 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-094 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-094 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
| 33342-094 | rizatriptan benzoate | rizatriptan benzoate | Macleods Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 32383 | ORIG | 2014-09-23 |