Application 075269
- 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 | 30MG | No | No |
| 002 | NIFEDIPINE | NIFEDIPINE | TABLET, EXTENDED RELEASE;ORAL | 60MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43353-209 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-4234 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-4234 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5284 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5284 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 50090-5284 | Nifedipine | Nifedipine | A-S Medication Solutions | ANDA | Current |
| 51655-798 | Nifedipine | Nifedipine | Northwind Pharmaceuticals | ANDA | Current |
| 53808-0388 | Nifediac CC | Nifedipine | State of Florida DOH Central Pharmacy | ANDA | Current |
| 64725-2057 | Nifedipine | Nifedipine | TYA Pharmaceuticals | ANDA | Current |
| 68071-3287 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3315 | Nifedipine | Nifedipine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68682-105 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-105 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-105 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-106 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-106 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 68682-106 | Nifedipine | Nifedipine | Oceanside Pharmaceuticals | ANDA | Current |
| 71610-012 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-012 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-012 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-144 | Nifedipine | Nifedipine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 42968 | ORIG | 2005-07-22 |
| 8589 | ORIG | 2004-06-10 |
| 30827 | ORIG | 2000-12-04 |