Application 201835

Type: ANDA
Sponsor: SAGENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	20MG/ML	No	No
002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	INJECTABLE;INJECTION	40MG/ML	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A201835-001	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27
A201835-002	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27
A201835-003	METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201835-002	AB
A201835-003	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-002	METHYLPREDNISOLONE ACETATE	40MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-003	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE / INJECTION	AB	RS	2018-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201835-001	METHYLPREDNISOLONE ACETATE	20MG/ML	INJECTABLE / INJECTION			2018-06-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A201835-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201835-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201835-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201835-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201835-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201835-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201835-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201835-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201835-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201835-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201835-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201835-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201835-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201835-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201835-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201835-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201835-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201835-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201835-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201835-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201835-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201835-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201835-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201835-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201835-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201835-003	AB	1	`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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sportpharm LLC	904b098c-9068-42ed-958f-6ab78ea42b1f	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201835 application number: ANDA201835
methylprednisolone acetate	METHYLPREDNISOLONE ACETATE	Sagent Pharmaceuticals	f98314ea-a4e4-4f78-987b-3e9b45a08bb4	2025-03-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201835 application number: ANDA201835 ndc (product): 25021-820 ndc (product): 25021-821

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-820	methylprednisolone acetate	methylprednisolone acetate	Sagent Pharmaceuticals	ANDA	Current
25021-820	methylprednisolone acetate	methylprednisolone acetate	Sagent Pharmaceuticals	ANDA	Current
25021-821	methylprednisolone acetate	methylprednisolone acetate	Sagent Pharmaceuticals	ANDA	Current
25021-821	methylprednisolone acetate	methylprednisolone acetate	Sagent Pharmaceuticals	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64842	ORIG	2020-10-06