Application 090527
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 002 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 25MG | No | No |
| 003 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 004 | HYDRALAZINE HYDROCHLORIDE | HYDRALAZINE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 35356-944 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0138 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2423 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53808-0882 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 68462-341 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-342 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-343 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |
| 68462-344 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Glenmark Pharmaceuticals Inc., USA | ANDA | Current |