Application 076070
- Type
- ANDA
- Sponsor
- VALEANT PHARMS NORTH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 90MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 53808-0500 | Nifediac CC | Nifedipine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55700-258 | Nifedipine | Nifedipine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 68071-3382 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68682-107 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-107 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-107 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 71610-055 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43048 | ORIG | 2005-07-22 |