Application 076523
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEFLOQUINE HYDROCHLORIDE | MEFLOQUINE HYDROCHLORIDE | TABLET;ORAL | 250MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-0025 | Mefloquine Hydrochloride | mefloquine hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0025 | Mefloquine Hydrochloride | mefloquine hydrochloride | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-0025 | Mefloquine Hydrochloride | mefloquine hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0054-0025 | Mefloquine Hydrochloride | mefloquine hydrochloride | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 39511 | SUPPL | 2013-07-29 |