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 44.

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 · 122 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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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…`
2021-12-28 21:50 UTC	2021-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008975-001	PURIFIED CORTROPHIN GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008975-002	PURIFIED CORTROPHIN GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 34 · 1,324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3917	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3918	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3919	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3920	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3921	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3922	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3923	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3924	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3925	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3926	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3904	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3905	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3906	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3907	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3908	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3909	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3910	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3911	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3912	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3913	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3914	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3915	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-001	12102662	2043-10-27	U-3916	2024-10-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3904	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3905	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3906	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3907	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3908	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3909	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3910	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3911	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3912	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3913	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3914	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3915	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3916	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3917	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3918	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3919	2024-05-17	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008975-002	11975047	2043-10-27	U-3920	2024-05-17	`c2088c7a36db…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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