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Application 211575
- Type
- ANDA
- Sponsor
- NOVITIUM PHARMA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | PREDNISONE | PREDNISONE | TABLET;ORAL | 2.5MG | No | No |
| 002 | PREDNISONE | PREDNISONE | TABLET;ORAL | 5MG | No | No |
| 003 | PREDNISONE | PREDNISONE | TABLET;ORAL | 10MG | No | No |
| 004 | PREDNISONE | PREDNISONE | TABLET;ORAL | 20MG | No | No |
| 005 | PREDNISONE | PREDNISONE | TABLET;ORAL | 50MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 42291-768 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-768 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-769 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-769 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-770 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-770 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-771 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 42291-771 | Prednisone | Prednisone | AvKARE | ANDA | Current |
| 50090-6225 | Prednisone | Prednisone | A-S Medication Solutions | ANDA | Current |
| 67296-1419 | Prednisone | Prednisone | RedPharm Drug, Inc. | ANDA | Current |
| 70518-3142 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-3142 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70518-3142 | Prednisone | Prednisone | REMEDYREPACK INC. | ANDA | Current |
| 70954-057 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-057 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-057 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-058 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-058 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-058 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-059 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-059 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-059 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-060 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-060 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-060 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-061 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-061 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 70954-061 | Prednisone | Prednisone | Novitium Pharma LLC | ANDA | Current |
| 71205-407 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-407 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-407 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-407 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-421 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71205-665 | Prednisone | Prednisone | Proficient Rx LP | ANDA | Current |
| 71335-1780 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1780 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |
| 71335-2160 | Prednisone | Prednisone | Bryant Ranch Prepack | ANDA | Current |