Application 090381
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | TABLET;ORAL | EQ 2.5MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0278 | Naratriptan | Naratriptan | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0278 | Naratriptan | Naratriptan | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0279 | Naratriptan | Naratriptan | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0279 | Naratriptan | Naratriptan | West-Ward Pharmaceuticals Corp. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31465 | ORIG | 2010-07-09 |