Application 087535

Type: ANDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
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.

Product history page 1 of 3 · 86 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	A087535-001	METHYLPREDNISOLONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1982-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A087535-002	METHYLPREDNISOLONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1982-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A087535-001	METHYLPREDNISOLONE	EQ 500MG BASE/VIAL	INJECTABLE / INJECTION	1982-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A087535-002	METHYLPREDNISOLONE	EQ 1GM BASE/VIAL	INJECTABLE / INJECTION	1982-06-25	`caaa826d4ba7…`
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…`

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 3 of 3 · 60 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f4304-bf37-da04-e053-2a95a90a4044	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
Methylprednisolone	METHYLPREDNISOLONE	Advanced Rx Pharmacy of Tennessee, LLC	f19f3676-856f-e8d7-e053-2995a90ad703	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
methylprednisolone	METHYLPREDNISOLONE	Zydus Lifesciences Limited	fe9c15b5-4264-45f1-87b5-f7e1d6e6ddee	2024-12-05		Name fallback brand name: methylprednisolone
Methylprednisolone	METHYLPREDNISOLONE	A-S Medication Solutions	eb479561-142d-410c-84b2-988375c6a96e	2024-10-02	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
Methylprednisolone	METHYLPREDNISOLONE	Chartwell RX, LLC	bdd048bb-7e6c-45c7-b51a-075e83ca9f5b	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
METHYLPREDNISOLONE	METHYLPREDNISOLONE	NuCare Pharmaceuticals,Inc.	a1dae00d-1ad3-7493-e053-2a95a90af49f	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE
Methylprednisolone sodium succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Dr. Reddy's Laboratories Inc	738753c7-507d-4881-5194-02dd7597768b	2024-06-17	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	01f0126c-da22-4ac0-8755-3bc589602e6a	2024-04-12	Warnings, Adverse reactions	Name fallback brand name: MethylPREDNISolone
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	cbe5f72a-b0fb-4abb-abfe-2f917d351a00	2023-09-26	Warnings, Adverse reactions	Name fallback brand name: MethylPREDNISolone
methylprednisolone	METHYLPREDNISOLONE	Proficient Rx LP	177fd649-4339-4bfd-bd12-7e8de302412b	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone
MethylPREDNISolone	METHYLPREDNISOLONE	Bryant Ranch Prepack	56c24076-3d5e-4235-a787-ec6329497084	2023-08-11	Warnings, Adverse reactions	Name fallback brand name: MethylPREDNISolone
Methylprednisolone	METHYLPREDNISOLONE	Proficient Rx LP	283a913e-f737-478e-b6a0-e050fb6562d8	2023-07-01	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	6a26a977-95dd-cdae-e053-2a91aa0a8b0a	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	dd2bfa31-9eae-2baa-e053-2a95a90a9db7	2023-05-23	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	Medical Purchasing Solutions, LLC	b635e21b-d68d-f60b-e053-2995a90a0f46	2023-05-08	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE SODIUM SUCCINATE	Fresenius Kabi USA, LLC	c5d22210-73c6-4697-a267-75e243508642	2023-03-02	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bfdc471-54f7-4298-ba2f-e5c1f6c48456	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Proficient Rx LP	3e37236f-8ba8-4a1c-87c8-62b787890fae	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Doc Rx	c6ec50b5-aeb8-40c3-83e2-af4fe8fefb14	2021-06-11	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE
METHYLPREDNISOLONE	METHYLPREDNISOLONE	Asclemed USA, Inc.	8bff5330-c1f6-4014-aadb-45c1726248dd	2021-03-16	Warnings, Adverse reactions	Name fallback brand name: METHYLPREDNISOLONE

Reported adverse events (FAERS/openFDA)#

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