Application 008372

Type: NDA
Sponsor: MALLINCKRODT ARD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	ACTHAR GEL (AUTOINJECTOR)	CORTICOTROPIN	INJECTABLE;INJECTION	40 UNITS/0.5ML	Yes	Yes
004	ACTHAR GEL (AUTOINJECTOR)	CORTICOTROPIN	INJECTABLE;INJECTION	80 UNITS/ML	Yes	Yes
006	H.P. ACTHAR GEL	CORTICOTROPIN	INJECTABLE;INJECTION	40 UNITS/ML	No	No
008	H.P. ACTHAR GEL	CORTICOTROPIN	INJECTABLE;INJECTION	80 UNITS/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N008372-003	ACTHAR GEL (AUTOINJECTOR)	CORTICOTROPIN	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29
N008372-004	ACTHAR GEL (AUTOINJECTOR)	CORTICOTROPIN	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29
N008372-006	ACTHAR GEL	CORTICOTROPIN	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982
N008372-008	ACTHAR GEL	CORTICOTROPIN	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N008372-003	11752199	2041-07-18	U-3686	2024-07-31
N008372-003	11752199	2041-07-18	U-3687	2024-07-31
N008372-003	11752199	2041-07-18	U-3688	2024-07-31
N008372-004	11752199	2041-07-18	U-3686	2024-07-31
N008372-004	11752199	2041-07-18	U-3687	2024-07-31
N008372-004	11752199	2041-07-18	U-3688	2024-07-31
N008372-008	11752199	2041-07-18	U-3686	2023-09-21
N008372-008	11752199	2041-07-18	U-3687	2023-09-21
N008372-008	11752199	2041-07-18	U-3688	2023-09-21

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 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 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	N008372-003	11752199	2041-07-18	U-3686	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-003	11752199	2041-07-18	U-3687	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-003	11752199	2041-07-18	U-3688	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-004	11752199	2041-07-18	U-3686	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-004	11752199	2041-07-18	U-3687	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-004	11752199	2041-07-18	U-3688	2024-07-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-008	11752199	2041-07-18	U-3686	2023-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-008	11752199	2041-07-18	U-3687	2023-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N008372-008	11752199	2041-07-18	U-3688	2023-09-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N008372-003	11752199	2041-07-18	U-3686	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-003	11752199	2041-07-18	U-3687	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-003	11752199	2041-07-18	U-3688	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-004	11752199	2041-07-18	U-3686	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-004	11752199	2041-07-18	U-3687	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-004	11752199	2041-07-18	U-3688	2024-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-008	11752199	2041-07-18	U-3686	2023-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-008	11752199	2041-07-18	U-3687	2023-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N008372-008	11752199	2041-07-18	U-3688	2023-09-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008372-003	11752199	2041-07-18	U-3686	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-003	11752199	2041-07-18	U-3687	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-003	11752199	2041-07-18	U-3688	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-004	11752199	2041-07-18	U-3686	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-004	11752199	2041-07-18	U-3687	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-004	11752199	2041-07-18	U-3688	2024-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-008	11752199	2041-07-18	U-3686	2023-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-008	11752199	2041-07-18	U-3687	2023-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N008372-008	11752199	2041-07-18	U-3688	2023-09-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008372-003	11752199	2041-07-18	U-3686	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-003	11752199	2041-07-18	U-3687	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-003	11752199	2041-07-18	U-3688	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-004	11752199	2041-07-18	U-3686	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-004	11752199	2041-07-18	U-3687	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-004	11752199	2041-07-18	U-3688	2024-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-008	11752199	2041-07-18	U-3686	2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-008	11752199	2041-07-18	U-3687	2023-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N008372-008	11752199	2041-07-18	U-3688	2023-09-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-003	11752199	2041-07-18	U-3686	2024-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-003	11752199	2041-07-18	U-3687	2024-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-003	11752199	2041-07-18	U-3688	2024-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008372-004	11752199	2041-07-18	U-3686	2024-07-31	`31067a03dcf5…`

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63004-8710	Acthar	Repository Corticotropin	Mallinckrodt ARD LLC	NDA	Current
63004-8710	Acthar	Repository Corticotropin	Mallinckrodt ARD LLC	NDA	Current
63004-8710	Acthar	Repository Corticotropin	Mallinckrodt ARD LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
77683	SUPPL	2024-03-01
77681	SUPPL	2024-03-01
77680	SUPPL	2024-03-01
73595	SUPPL	2023-02-23
69179	SUPPL	2021-11-01
69173	SUPPL	2021-10-29
69172	SUPPL	2021-10-29
66472	SUPPL	2021-03-03
66471	SUPPL	2021-03-03
66460	SUPPL	2021-03-03
58092	SUPPL	2019-03-27
58081	SUPPL	2019-03-27
53889	SUPPL	2018-05-01
53826	SUPPL	2018-04-27
32963	SUPPL	2015-05-08
150	SUPPL	2015-03-25
98	SUPPL	2012-07-09