Application 200737
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| 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 | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-290 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-291 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-292 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |
| 67877-293 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Ascend Laboratories, LLC | ANDA | Current |