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 2 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
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008372-008	ACTHAR 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	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008372-003	ACTHAR GEL (AUTOINJECTOR)	40 UNITS/0.5ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008372-004	ACTHAR GEL (AUTOINJECTOR)	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS	2024-02-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N008372-008	ACTHAR 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	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008372-006	H.P. ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N008372-008	H.P. ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008372-006	ACTHAR GEL	40 UNITS/ML	INJECTABLE / INJECTION	Approved before 1982		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N008372-008	ACTHAR GEL	80 UNITS/ML	INJECTABLE / INJECTION	RLD, RS, Approved before 1982		`782e0a99824c…`

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…`

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
Acthar	REPOSITORY CORTICOTROPIN	Mallinckrodt ARD LLC	7b48ddec-e815-45f4-9ca0-5c0daaf56f30	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 008372 application number: NDA008372 ndc (product): 63004-8710

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