Application 008975

Type: NDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PURIFIED CORTROPHIN GEL	CORTICOTROPIN	INJECTABLE;INJECTION	40 UNITS/ML	No	No
002	PURIFIED CORTROPHIN GEL	CORTICOTROPIN	INJECTABLE;INJECTION	80 UNITS/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
N008975-001	PURIFIED CORTROPHIN GEL	CORTICOTROPIN	40 UNITS/ML	INJECTABLE / INJECTION		Approved before 1982
N008975-002	PURIFIED CORTROPHIN GEL	CORTICOTROPIN	80 UNITS/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982

Orange Book patents#

Current patent rows page 1 of 2 · 116 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N008975-001	12102662	2043-10-27	U-3904	2024-10-04
N008975-001	12102662	2043-10-27	U-3905	2024-10-04
N008975-001	12102662	2043-10-27	U-3906	2024-10-04
N008975-001	12102662	2043-10-27	U-3907	2024-10-04
N008975-001	12102662	2043-10-27	U-3908	2024-10-04
N008975-001	12102662	2043-10-27	U-3909	2024-10-04
N008975-001	12102662	2043-10-27	U-3910	2024-10-04
N008975-001	12102662	2043-10-27	U-3911	2024-10-04
N008975-001	12102662	2043-10-27	U-3912	2024-10-04
N008975-001	12102662	2043-10-27	U-3913	2024-10-04
N008975-001	12102662	2043-10-27	U-3914	2024-10-04
N008975-001	12102662	2043-10-27	U-3915	2024-10-04
N008975-001	12102662	2043-10-27	U-3916	2024-10-04
N008975-001	12102662	2043-10-27	U-3917	2024-10-04
N008975-001	12102662	2043-10-27	U-3918	2024-10-04
N008975-001	12102662	2043-10-27	U-3919	2024-10-04
N008975-001	12102662	2043-10-27	U-3920	2024-10-04
N008975-001	12102662	2043-10-27	U-3921	2024-10-04
N008975-001	12102662	2043-10-27	U-3922	2024-10-04
N008975-001	12102662	2043-10-27	U-3923	2024-10-04
N008975-001	12102662	2043-10-27	U-3924	2024-10-04
N008975-001	12102662	2043-10-27	U-3925	2024-10-04
N008975-001	12102662	2043-10-27	U-3926	2024-10-04
N008975-002	11975047	2043-10-27	U-3904	2024-05-17
N008975-002	11975047	2043-10-27	U-3905	2024-05-17
N008975-002	11975047	2043-10-27	U-3906	2024-05-17
N008975-002	11975047	2043-10-27	U-3907	2024-05-17
N008975-002	11975047	2043-10-27	U-3908	2024-05-17
N008975-002	11975047	2043-10-27	U-3909	2024-05-17
N008975-002	11975047	2043-10-27	U-3910	2024-05-17
N008975-002	11975047	2043-10-27	U-3911	2024-05-17
N008975-002	11975047	2043-10-27	U-3912	2024-05-17
N008975-002	11975047	2043-10-27	U-3913	2024-05-17
N008975-002	11975047	2043-10-27	U-3914	2024-05-17
N008975-002	11975047	2043-10-27	U-3915	2024-05-17
N008975-002	11975047	2043-10-27	U-3916	2024-05-17
N008975-002	11975047	2043-10-27	U-3917	2024-05-17
N008975-002	11975047	2043-10-27	U-3918	2024-05-17
N008975-002	11975047	2043-10-27	U-3919	2024-05-17
N008975-002	11975047	2043-10-27	U-3920	2024-05-17
N008975-002	11975047	2043-10-27	U-3921	2024-05-17
N008975-002	11975047	2043-10-27	U-3922	2024-05-17
N008975-002	11975047	2043-10-27	U-3923	2024-05-17
N008975-002	11975047	2043-10-27	U-3924	2024-05-17
N008975-002	11975047	2043-10-27	U-3925	2024-05-17
N008975-002	11975047	2043-10-27	U-3926	2024-05-17
N008975-002	12102662	2043-10-27	U-3904	2024-10-04
N008975-002	12102662	2043-10-27	U-3905	2024-10-04
N008975-002	12102662	2043-10-27	U-3906	2024-10-04
N008975-002	12102662	2043-10-27	U-3907	2024-10-04
N008975-002	12102662	2043-10-27	U-3908	2024-10-04
N008975-002	12102662	2043-10-27	U-3909	2024-10-04
N008975-002	12102662	2043-10-27	U-3910	2024-10-04
N008975-002	12102662	2043-10-27	U-3911	2024-10-04
N008975-002	12102662	2043-10-27	U-3912	2024-10-04
N008975-002	12102662	2043-10-27	U-3913	2024-10-04
N008975-002	12102662	2043-10-27	U-3914	2024-10-04
N008975-002	12102662	2043-10-27	U-3915	2024-10-04
N008975-002	12102662	2043-10-27	U-3916	2024-10-04
N008975-002	12102662	2043-10-27	U-3917	2024-10-04
N008975-002	12102662	2043-10-27	U-3918	2024-10-04
N008975-002	12102662	2043-10-27	U-3919	2024-10-04
N008975-002	12102662	2043-10-27	U-3920	2024-10-04
N008975-002	12102662	2043-10-27	U-3921	2024-10-04
N008975-002	12102662	2043-10-27	U-3922	2024-10-04
N008975-002	12102662	2043-10-27	U-3923	2024-10-04
N008975-002	12102662	2043-10-27	U-3924	2024-10-04
N008975-002	12102662	2043-10-27	U-3925	2024-10-04
N008975-002	12102662	2043-10-27	U-3926	2024-10-04
N008975-002	12233105	2043-10-27	U-3904	2025-03-05
N008975-002	12233105	2043-10-27	U-3905	2025-03-05
N008975-002	12233105	2043-10-27	U-3906	2025-03-05
N008975-002	12233105	2043-10-27	U-3907	2025-03-05
N008975-002	12233105	2043-10-27	U-3908	2025-03-05
N008975-002	12233105	2043-10-27	U-3909	2025-03-05
N008975-002	12233105	2043-10-27	U-3910	2025-03-05
N008975-002	12233105	2043-10-27	U-3911	2025-03-05
N008975-002	12233105	2043-10-27	U-3912	2025-03-05
N008975-002	12233105	2043-10-27	U-3913	2025-03-05
N008975-002	12233105	2043-10-27	U-3914	2025-03-05

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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 28 · 1,086 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3917	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3918	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3919	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3920	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3921	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3922	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3923	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3924	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3925	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3926	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3904	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3905	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3906	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3907	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3908	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3909	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3910	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3911	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3912	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3913	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3914	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3915	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-001	12102662	2043-10-27	U-3916	2024-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3904	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3905	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3906	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3907	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3908	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3909	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3910	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3911	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3912	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3913	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3914	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3915	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3916	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3917	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3918	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3919	2024-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008975-002	11975047	2043-10-27	U-3920	2024-05-17	`caaa826d4ba7…`

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
Purified Cortrophin Gel	REPOSITORY CORTICOTROPIN	ANI Pharmaceuticals, Inc.	f27544ee-a0e2-4d84-b193-1c9efdf9e34c	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008975 application number: NDA008975 ndc (product): 62559-860

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62559-860	Purified Cortrophin Gel	Repository Corticotropin	ANI Pharmaceuticals, Inc.	NDA	Current
62559-860	Purified Cortrophin Gel	Repository Corticotropin	ANI Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81414	SUPPL	2025-03-04
81413	SUPPL	2025-03-04
80588	SUPPL	2024-12-16
80578	SUPPL	2024-12-16
77423	SUPPL	2024-02-08
75980	SUPPL	2023-10-27
75966	SUPPL	2023-10-27
70716	SUPPL	2022-04-07