Application 210043

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	40MG/ML	No	No
002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	80MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A210043-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20
A210043-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210043-001	AB
A210043-002	AB

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2019-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION			2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION			2019-05-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210043-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210043-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2019-05-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210043-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210043-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210043-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210043-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210043-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210043-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210043-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210043-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210043-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210043-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210043-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210043-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210043-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210043-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210043-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210043-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210043-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210043-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210043-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210043-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210043-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210043-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210043-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210043-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210043-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210043-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210043-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210043-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210043-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210043-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210043-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210043-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210043-002	AB	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sportpharm LLC	62f4339a-a971-414d-b407-ef030fe4f989	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals NY LLC	8ea42650-21cd-49e4-92c8-48f2eeaf95bc	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043 ndc (product): 60219-1574 ndc (product): 60219-1573
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals LLC	3184a75e-61c5-4281-abf0-4eab861ca009	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043 ndc (product): 70121-1552
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals LLC	d944240d-2c19-46ba-ad4f-3fbee7b8629c	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043 ndc (product): 70121-1573 ndc (product): 70121-1574
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	1084208f-3b86-4aef-8247-5b6ed6cd50c7	2025-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043 ndc (product): 50090-5894
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	2f47d739-c39f-47c2-9e3c-1aef2cf201b1	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210043 application number: ANDA210043 ndc (product): 50090-6024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5894	Methylprednisolone acetate	Methylprednisolone acetate	A-S Medication Solutions	ANDA	Current
50090-6024	Methylprednisolone acetate	Methylprednisolone acetate	A-S Medication Solutions	ANDA	Current
60219-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals NY LLC	ANDA	Current
60219-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals NY LLC	ANDA	Current
70121-1552	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1552	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1573	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Biosciences LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Pharmaceuticals LLC	ANDA	Current
70121-1574	Methylprednisolone acetate	Methylprednisolone acetate	Amneal Biosciences LLC	ANDA	Current
70518-2915	Methylprednisolone acetate	Methylprednisolone acetate	REMEDYREPACK INC.	ANDA	Current
70518-3071	Methylprednisolone acetate	Methylprednisolone acetate	REMEDYREPACK INC.	ANDA	Current