Application 214297

Type: ANDA
Sponsor: PAR STERILE PRODUCTS

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 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
A214297-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB		2022-01-21
A214297-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB		2022-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214297-001	AB
A214297-002	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 2 · 64 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	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214297-001	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214297-002	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	2022-01-21	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A214297-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214297-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214297-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214297-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214297-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214297-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214297-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214297-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214297-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214297-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214297-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214297-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214297-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214297-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214297-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214297-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214297-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214297-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214297-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214297-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214297-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214297-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214297-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214297-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214297-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214297-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214297-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214297-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214297-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214297-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214297-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214297-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214297-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214297-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214297-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214297-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214297-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214297-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214297-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214297-002	AB	1	`1c564ffb4f44…`

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 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylprednisolone Acetate	METHYLPREDNISOLONE ACETATE	Eugia US LLC	a0cbcdb5-f657-49f7-8f86-cc5959d69db0	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Acetate generic name: METHYLPREDNISOLONE ACETATE
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sportpharm LLC	904b098c-9068-42ed-958f-6ab78ea42b1f	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone Acetate	METHYLPREDNISOLONE ACETATE	Caplin Steriles Limited	23f98766-7571-49cb-8c1a-58fabba53965	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone Acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sportpharm LLC	62f4339a-a971-414d-b407-ef030fe4f989	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	823b0010-2b57-4e76-b5ac-4a8c2963438f	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	9a7b3837-e038-48bf-97e9-78ad463760dc	2026-01-21	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals NY LLC	8ea42650-21cd-49e4-92c8-48f2eeaf95bc	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals LLC	3184a75e-61c5-4281-abf0-4eab861ca009	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals LLC	de12f38c-ffa1-4d62-b9cb-238a263f6fea	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Amneal Pharmaceuticals LLC	d944240d-2c19-46ba-ad4f-3fbee7b8629c	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Depo-Medrol	METHYLPREDNISOLONE ACETATE	Pharmacia & Upjohn Company LLC	bf1b104d-85cb-414d-a366-78068c82c883	2025-12-01	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	1084208f-3b86-4aef-8247-5b6ed6cd50c7	2025-11-07	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	cb457bef-8823-4f3c-987b-eb0922494c46	2025-11-06	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	d75f6751-9ac3-416f-8470-6c011aacf755	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	e8209047-c1e6-4081-a6d3-c603d9ee4f14	2025-10-27	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sagent Pharmaceuticals	f98314ea-a4e4-4f78-987b-3e9b45a08bb4	2025-03-02	Warnings, Adverse reactions	Name fallback brand name: methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	2f47d739-c39f-47c2-9e3c-1aef2cf201b1	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Methylprednisolone acetate generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	A-S Medication Solutions	aa151d12-bd33-4d26-848f-2195172c9700	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
Medroloan SUIK	METHYLPREDNISOLONE ACETATE	Asclemed USA, Inc.	7867127f-aab1-494f-8c3d-e521ed578c3a	2022-12-09	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE
Medroloan II SUIK	METHYLPREDNISOLONE ACETATE	Asclemed USA, Inc.	18dacdba-793c-490d-aa73-9e76bec41fae	2022-12-09	Warnings, Adverse reactions	Name fallback generic name: METHYLPREDNISOLONE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42023-240	Methylprednisolone Acetate	Methylprednisolone Acetate	Par Pharmaceutical, Inc.	ANDA	Current
42023-240	Methylprednisolone Acetate	Methylprednisolone Acetate	Par Pharmaceutical, Inc.	ANDA	Current
42023-240	Methylprednisolone Acetate	Methylprednisolone Acetate	Par Pharmaceutical, Inc.	ANDA	Current