Application 085855
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | A-METHAPRED | METHYLPREDNISOLONE SODIUM SUCCINATE | INJECTABLE;INJECTION | EQ 125MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A085855-001 | A-METHAPRED | METHYLPREDNISOLONE SODIUM SUCCINATE | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A085855-001 | A-METHAPRED | EQ 125MG BASE/VIAL | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | Pharmacia & Upjohn Company LLC | 7271310c-7764-4812-aa30-a5e90987c7a9 | 2026-06-25 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Eugia US LLC | 2035f00e-2299-473a-b004-cb93f541cfa9 | 2026-06-12 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| 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 |
| Solu-Medrol | METHYLPREDNISOLONE SODIUM SUCCINATE | Cardinal Health 107, LLC | 2af28649-2553-4bcc-9cb1-c73f7cec76d5 | 2026-05-20 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| 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 |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Hikma Pharmaceuticals USA Inc. | 060bcf13-ce9e-488c-ad43-9d66abb23b18 | 2026-02-17 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| Methylprednisolone Sodium Succinate | METHYLPREDNISOLONE SODIUM SUCCINATE | Civica, Inc. | 2e6020f5-a486-41cc-8956-58b5f6751aa2 | 2026-02-17 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| 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 |
| SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | REMEDYREPACK INC. | 1d5ef347-2e9a-432f-9a88-a7c4ba300267 | 2026-01-30 | Warnings, Adverse reactions | METHYLPREDNISOLONE SODIUM SUCCINATE |
| 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 |
| 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 |