Application 087851

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION			1983-02-09

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087851-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1983-02-09	`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.

Matched openFDA labels page 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	HF Acquisition Co LLC, DBA HealthFirst	559427ac-9fc6-96f5-e063-6294a90a0b30	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE SODIUM SUCCINATE generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Sportpharm LLC	0cb0ba76-067f-46c4-a5d8-b585d5ecafe3	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	68ef8ec4-16de-4a8c-8696-b09359660380	2026-07-17	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Pharmacia & Upjohn Company LLC	7271310c-7764-4812-aa30-a5e90987c7a9	2026-06-25	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Eugia US LLC	2035f00e-2299-473a-b004-cb93f541cfa9	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	ea2f9b6f-2375-40a6-8b97-b607b9f3ac63	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	A-S Medication Solutions	8e5997ed-f4a5-43f7-abbd-c8e2219fe0e9	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	2af28649-2553-4bcc-9cb1-c73f7cec76d5	2026-05-20	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone sodium succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	REMEDYREPACK INC.	f339882f-c380-4022-bdcd-94556a7926aa	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone sodium succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Henry Schein, Inc.	decceb81-e922-4b72-a278-3ed80f4adb04	2026-03-18	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Hikma Pharmaceuticals USA Inc.	060bcf13-ce9e-488c-ad43-9d66abb23b18	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Civica, Inc.	2e6020f5-a486-41cc-8956-58b5f6751aa2	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Hikma Pharmaceuticals USA Inc.	05d95a56-b03a-4d5b-9877-2853ac470fa1	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Hikma Pharmaceuticals USA Inc.	2e540674-0915-4498-8e2b-751c7e97532a	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	REMEDYREPACK INC.	1d5ef347-2e9a-432f-9a88-a7c4ba300267	2026-01-30	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-Medrol	METHYLPREDNISOLONE SODIUM SUCCINATE	Cardinal Health 107, LLC	7e38b09c-da41-4ee3-8f99-812d3276d551	2025-12-19	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	ProPharma Distribution	42df21df-9284-4505-e063-6294a90a7024	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Tianjin Kingyork Pharmaceuticals Co., Ltd	77a8d96c-37df-4f3a-9757-b2d4131ff82b	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Amneal Pharmaceuticals LLC	e86fbda8-00e4-4d54-841a-59dea6c15e70	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Sodium Succinate

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.