Application 012421
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEDROL ACETATE | METHYLPREDNISOLONE ACETATE | OINTMENT;TOPICAL | 0.25% | No | No |
| 002 | MEDROL ACETATE | METHYLPREDNISOLONE ACETATE | OINTMENT;TOPICAL | 1% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012421-001 | MEDROL ACETATE | METHYLPREDNISOLONE ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | ||
| N012421-002 | MEDROL ACETATE | METHYLPREDNISOLONE ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012421-001 | MEDROL ACETATE | 0.25% | OINTMENT / TOPICAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012421-002 | MEDROL ACETATE | 1% | OINTMENT / TOPICAL | Approved before 1982 | 4b0b4de00fa7… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Methylprednisolone Acetate | METHYLPREDNISOLONE ACETATE | Eugia US LLC | a0cbcdb5-f657-49f7-8f86-cc5959d69db0 | 2026-04-21 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Sportpharm LLC | 904b098c-9068-42ed-958f-6ab78ea42b1f | 2026-04-01 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone Acetate | METHYLPREDNISOLONE ACETATE | Caplin Steriles Limited | 23f98766-7571-49cb-8c1a-58fabba53965 | 2026-02-06 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Sportpharm LLC | 62f4339a-a971-414d-b407-ef030fe4f989 | 2026-02-06 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Depo-Medrol | METHYLPREDNISOLONE ACETATE | Pharmacia & Upjohn Company LLC | 823b0010-2b57-4e76-b5ac-4a8c2963438f | 2026-01-21 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Depo-Medrol | METHYLPREDNISOLONE ACETATE | Pharmacia & Upjohn Company LLC | 9a7b3837-e038-48bf-97e9-78ad463760dc | 2026-01-21 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Amneal Pharmaceuticals NY LLC | 8ea42650-21cd-49e4-92c8-48f2eeaf95bc | 2026-01-19 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Amneal Pharmaceuticals LLC | 3184a75e-61c5-4281-abf0-4eab861ca009 | 2026-01-19 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Amneal Pharmaceuticals LLC | de12f38c-ffa1-4d62-b9cb-238a263f6fea | 2025-12-31 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Amneal Pharmaceuticals LLC | d944240d-2c19-46ba-ad4f-3fbee7b8629c | 2025-12-15 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Depo-Medrol | METHYLPREDNISOLONE ACETATE | Pharmacia & Upjohn Company LLC | bf1b104d-85cb-414d-a366-78068c82c883 | 2025-12-01 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | 1084208f-3b86-4aef-8247-5b6ed6cd50c7 | 2025-11-07 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | cb457bef-8823-4f3c-987b-eb0922494c46 | 2025-11-06 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | d75f6751-9ac3-416f-8470-6c011aacf755 | 2025-11-05 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | e8209047-c1e6-4081-a6d3-c603d9ee4f14 | 2025-10-27 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | Sagent Pharmaceuticals | f98314ea-a4e4-4f78-987b-3e9b45a08bb4 | 2025-03-02 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Methylprednisolone acetate | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | 2f47d739-c39f-47c2-9e3c-1aef2cf201b1 | 2024-06-03 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| DEPO-MEDROL | METHYLPREDNISOLONE ACETATE | A-S Medication Solutions | aa151d12-bd33-4d26-848f-2195172c9700 | 2024-06-03 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Medroloan SUIK | METHYLPREDNISOLONE ACETATE | Asclemed USA, Inc. | 7867127f-aab1-494f-8c3d-e521ed578c3a | 2022-12-09 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
| Medroloan II SUIK | METHYLPREDNISOLONE ACETATE | Asclemed USA, Inc. | 18dacdba-793c-490d-aa73-9e76bec41fae | 2022-12-09 | Warnings, Adverse reactions | METHYLPREDNISOLONE ACETATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.