Application 216067
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 30MG | No | No |
| 002 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
| 003 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67877-756 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-756 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-757 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-757 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-758 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |
| 67877-758 | Nifedipine | Nifedipine | Ascend Laboratories, LLC | ANDA | Current |