Application 074670
- Type
- ANDA
- Sponsor
- ANI PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 20MG | No | No |
| 002 | NICARDIPINE HYDROCHLORIDE | NICARDIPINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62559-205 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-205 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-206 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |
| 62559-206 | Nicardipine Hydrochloride | Nicardipine Hydrochloride | ANI Pharmaceuticals, Inc. | ANDA | Current |