Application 087535
- Type
- ANDA
- Sponsor
- ORGANON USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | No | No |
| 002 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 1GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087535-001 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | ||
| A087535-002 | METHYLPREDNISOLONE | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 782e0a99824c… |
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 Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Civica, Inc. | 2e6020f5-a486-41cc-8956-58b5f6751aa2 | 2026-02-17 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | REMEDYREPACK INC. | 445e59a6-8886-48e7-8116-253a82144934 | 2026-02-13 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Hikma Pharmaceuticals USA Inc. | 05d95a56-b03a-4d5b-9877-2853ac470fa1 | 2026-02-13 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Hikma Pharmaceuticals USA Inc. | 2e540674-0915-4498-8e2b-751c7e97532a | 2026-02-13 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | Sportpharm LLC | fd9f28a0-fd86-4767-876c-8520fddeccd2 | 2026-02-06 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | REMEDYREPACK INC. | 1d5ef347-2e9a-432f-9a88-a7c4ba300267 | 2026-01-30 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | Tianjin Tianyao Pharmaceuticals Co., Ltd. | e09eefd2-f423-40cb-87b6-3ee97e7f831b | 2026-01-22 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | PHOENIX RX LLC | 476ef50d-7e77-75f6-e063-6294a90a26e4 | 2026-01-02 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | Epic Pharma, LLC | b1908c2a-c596-4e2a-b2bd-0745d4fea31a | 2026-01-02 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| methylprednisolone | METHYLPREDNISOLONE | Major Pharmaceuticals | 3885151c-963e-4d22-b5b4-58968503ad8c | 2025-12-26 | Warnings, Adverse reactions | methylprednisolone |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Cardinal Health 107, LLC | 7e38b09c-da41-4ee3-8f99-812d3276d551 | 2025-12-19 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | ProPharma Distribution | 42df21df-9284-4505-e063-6294a90a7024 | 2025-12-18 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | Pharmacia & Upjohn Company LLC | cd99be87-c8d9-48d6-a8e5-e081052e3f19 | 2025-12-02 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| methylprednisolone | METHYLPREDNISOLONE | Zydus Pharmaceuticals USA Inc. | eaa9c932-c659-4ef6-bf5a-186545d87320 | 2025-11-10 | Warnings, Adverse reactions | methylprednisolone |
| Methylprednisolone | METHYLPREDNISOLONE | REMEDYREPACK INC. | d2a0e52c-f724-40e6-9d2a-5f1487c104b6 | 2025-09-29 | Warnings, Adverse reactions | Methylprednisolone |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | ProPharma Distribution | 38698075-ac58-b5a4-e063-6294a90a7848 | 2025-07-18 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | REMEDYREPACK INC. | ae524bdb-9fd0-49f9-802d-465a374c175b | 2025-05-27 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| MethylPREDNISolone | METHYLPREDNISOLONE | PD-Rx Pharmaceuticals, Inc. | a14c4f76-6dd5-4c84-b6e5-e5abf19ab559 | 2025-03-20 | Warnings, Adverse reactions | MethylPREDNISolone |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | Direct_Rx | 8c3f3f63-8a05-7a4a-e053-2995a90ad95a | 2025-01-20 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| Methylprednisolone | METHYLPREDNISOLONE | Advanced Rx Pharmacy of Tennessee, LLC | f19f6120-3c25-2a28-e053-2a95a90a86d5 | 2024-12-31 | Warnings, Adverse reactions | Methylprednisolone |