Application 207549

Type: ANDA
Sponsor: AMNEAL

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 40MG BASE/VIAL	No	No
002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	INJECTABLE;INJECTION	EQ 125MG BASE/VIAL	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-09
A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP		2016-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207549-001	AP
A207549-002	AP

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207549-001	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207549-002	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE / INJECTION	AP	2016-11-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207549-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207549-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207549-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207549-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207549-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207549-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207549-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207549-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207549-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207549-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207549-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207549-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207549-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207549-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207549-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207549-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207549-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207549-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207549-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207549-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207549-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207549-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207549-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207549-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207549-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207549-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207549-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207549-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207549-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207549-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207549-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207549-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207549-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207549-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207549-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207549-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207549-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207549-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207549-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207549-002	AP	1	`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.

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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone Sodium Succinate	METHYLPREDNISOLONE	Amneal Pharmaceuticals LLC	e86fbda8-00e4-4d54-841a-59dea6c15e70	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207549 application number: ANDA207549 ndc (product): 70121-1001 ndc (product): 70121-1000

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70121-1000	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1000	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1000	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1000	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Biosciences LLC	ANDA	Current
70121-1000	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1001	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1001	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1001	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1001	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Biosciences LLC	ANDA	Current
70121-1001	Methylprednisolone Sodium Succinate	Methylprednisolone	Amneal Pharmaceuticals LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47112	ORIG	2017-02-07
46025	ORIG	2016-12-06