Application 011153
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 4MG | Yes | No |
| 002 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 2MG | Yes | No |
| 003 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 16MG | Yes | No |
| 004 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 8MG | Yes | No |
| 005 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 24MG | No | No |
| 006 | MEDROL | METHYLPREDNISOLONE | TABLET;ORAL | 32MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0020 | Medrol | methylprednisolone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0020 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0020 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0022 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0022 | Medrol | methylprednisolone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0022 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0056 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0056 | Medrol | methylprednisolone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0056 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0073 | Medrol | methylprednisolone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0073 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0073 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0176 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0176 | Medrol | methylprednisolone | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0176 | Medrol | methylprednisolone | Pharmacia and Upjohn Company LLC | NDA | Current |
| 49999-153 | Methylprednisolone | methylprednisolone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 49999-153 | Methylprednisolone | methylprednisolone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 49999-153 | Methylprednisolone | methylprednisolone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 49999-153 | Methylprednisolone | methylprednisolone | Lake Erie Medical DBA Quality Care Products LLC | NDA | Current |
| 50090-0092 | Medrol | methylprednisolone | A-S Medication Solutions | NDA | Current |
| 50090-0092 | Medrol | methylprednisolone | A-S Medication Solutions | NDA | Current |
| 50090-0092 | Medrol | methylprednisolone | A-S Medication Solutions | NDA | Current |
| 59762-0049 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0049 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0049 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0050 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0050 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0050 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0051 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0051 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0051 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4440 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4440 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4440 | Methylprednisolone | methylprednisolone | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 68071-2370 | Methylprednisolone | methylprednisolone | NuCare Pharmaceuticals,Inc. | NDA AUTHORIZED GENERIC | Current |
| 68387-170 | Methylprednisolone | methylprednisolone | Keltman Pharmaceuticals Inc. | NDA | Current |
| 70518-2041 | Medrol | methylprednisolone | REMEDYREPACK INC. | NDA | Current |
| 70518-2041 | Medrol | methylprednisolone | REMEDYREPACK INC. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 84122 | SUPPL | 2025-11-07 |
| 84066 | SUPPL | 2025-11-05 |
| 78704 | SUPPL | 2024-06-07 |
| 78672 | SUPPL | 2024-06-06 |
| 77106 | SUPPL | 2023-12-22 |
| 77098 | SUPPL | 2023-12-21 |
| 66314 | SUPPL | 2021-02-22 |
| 66204 | SUPPL | 2021-02-12 |
| 54996 | SUPPL | 2018-07-26 |
| 54965 | SUPPL | 2018-07-25 |
| 33035 | SUPPL | 2015-12-31 |