Home Applications 008372 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 TE codes 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 Coverage / status 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 4 of 4 · 124 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008372-003 ACTHAR GEL (AUTOINJECTOR) 40 UNITS/0.5ML INJECTABLE / INJECTION RLD, RS 2024-02-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008372-004 ACTHAR GEL (AUTOINJECTOR) 80 UNITS/ML INJECTABLE / INJECTION RLD, RS 2024-02-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008372-006 ACTHAR GEL 40 UNITS/ML INJECTABLE / INJECTION Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N008372-008 ACTHAR GEL 80 UNITS/ML INJECTABLE / INJECTION RLD, RS, Approved before 1982 a50c72e98297…
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 Coverage / status 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.
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