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 |
|---|---|---|---|---|---|---|---|---|---|
| 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… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A087535-001 | METHYLPREDNISOLONE | EQ 500MG BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A087535-002 | METHYLPREDNISOLONE | EQ 1GM BASE/VIAL | INJECTABLE / INJECTION | 1982-06-25 | f41ea6bd6efb… |
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 | REMEDYREPACK INC. | ae524bdb-9fd0-49f9-802d-465a374c175b | 2026-09-08 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Methylprednisolone | METHYLPREDNISOLONE | REMEDYREPACK INC. | d2a0e52c-f724-40e6-9d2a-5f1487c104b6 | 2026-08-31 | Warnings, Adverse reactions | Methylprednisolone |
| MethylPREDNISolone | METHYLPREDNISOLONE | PD-Rx Pharmaceuticals, Inc. | a14c4f76-6dd5-4c84-b6e5-e5abf19ab559 | 2026-08-10 | Warnings, Adverse reactions | MethylPREDNISolone |
| METHYLPREDNISOLONE SODIUM SUCCINATE | METHYLPREDNISOLONE SODIUM SUCCINATE | HF Acquisition Co LLC, DBA HealthFirst | 559427ac-9fc6-96f5-e063-6294a90a0b30 | 2026-07-24 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | Sportpharm LLC | 0cb0ba76-067f-46c4-a5d8-b585d5ecafe3 | 2026-07-23 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Cardinal Health 107, LLC | 68ef8ec4-16de-4a8c-8696-b09359660380 | 2026-07-17 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | HAWAII REPACK, INC. | d0d5fc54-69e1-4303-96be-3f97adec6074 | 2026-07-03 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| Methylprednisolone | METHYLPREDNISOLONE | American Health Packaging | 97256c7e-5694-4148-926f-594b9d5c34f4 | 2026-07-01 | Warnings, Adverse reactions | Methylprednisolone |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | Pharmacia & Upjohn Company LLC | 7271310c-7764-4812-aa30-a5e90987c7a9 | 2026-06-25 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | Preferred Pharmaceuticals Inc. | e27ab941-adc6-47b6-b217-08d095a851fd | 2026-06-23 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| Methylprednisolone | METHYLPREDNISOLONE | Mylan Pharmaceuticals Inc. | 22dd75d6-f89a-44f7-8ca6-b64c4e9806dd | 2026-06-22 | Warnings, Adverse reactions | Methylprednisolone |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Eugia US LLC | 2035f00e-2299-473a-b004-cb93f541cfa9 | 2026-06-12 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| METHYLPREDNISOLONE | METHYLPREDNISOLONE | St. Mary's Medical Park Pharmacy | 235ca8cf-1576-0dfd-e063-6394a90a8b25 | 2026-06-04 | Warnings, Adverse reactions | METHYLPREDNISOLONE |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Henry Schein, Inc. | ea2f9b6f-2375-40a6-8b97-b607b9f3ac63 | 2026-06-04 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | A-S Medication Solutions | 8e5997ed-f4a5-43f7-abbd-c8e2219fe0e9 | 2026-05-29 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| methylprednisolone | METHYLPREDNISOLONE | BluePoint Laboratories | 7092df48-4904-4047-9916-e585417a216f | 2026-05-22 | Warnings, Adverse reactions | methylprednisolone |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Cardinal Health 107, LLC | 2af28649-2553-4bcc-9cb1-c73f7cec76d5 | 2026-05-20 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| MethylPREDNISolone | METHYLPREDNISOLONE | Par Health USA, LLC | c84cf5e6-746d-41fb-b3d8-2c0b8ba989af | 2026-04-16 | Warnings, Adverse reactions | MethylPREDNISolone |
| Methylprednisolone sodium succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | REMEDYREPACK INC. | f339882f-c380-4022-bdcd-94556a7926aa | 2026-04-15 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Henry Schein, Inc. | decceb81-e922-4b72-a278-3ed80f4adb04 | 2026-03-18 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.