Application 008372

Type
NDA
Sponsor
MALLINCKRODT ARD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003ACTHAR GEL (AUTOINJECTOR)CORTICOTROPININJECTABLE;INJECTION40 UNITS/0.5MLYesYes
004ACTHAR GEL (AUTOINJECTOR)CORTICOTROPININJECTABLE;INJECTION80 UNITS/MLYesYes
006H.P. ACTHAR GELCORTICOTROPININJECTABLE;INJECTION40 UNITS/MLNoNo
008H.P. ACTHAR GELCORTICOTROPININJECTABLE;INJECTION80 UNITS/MLYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N008372-003ACTHAR GEL (AUTOINJECTOR)CORTICOTROPIN40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29
N008372-004ACTHAR GEL (AUTOINJECTOR)CORTICOTROPIN80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29
N008372-006ACTHAR GELCORTICOTROPIN40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982
N008372-008ACTHAR GELCORTICOTROPIN80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N008372-003117521992041-07-18U-36862024-07-31
N008372-003117521992041-07-18U-36872024-07-31
N008372-003117521992041-07-18U-36882024-07-31
N008372-004117521992041-07-18U-36862024-07-31
N008372-004117521992041-07-18U-36872024-07-31
N008372-004117521992041-07-18U-36882024-07-31
N008372-008117521992041-07-18U-36862023-09-21
N008372-008117521992041-07-18U-36872023-09-21
N008372-008117521992041-07-18U-36882023-09-21

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008372-003ACTHAR GEL (AUTOINJECTOR)40 UNITS/0.5MLINJECTABLE / INJECTIONRLD, RS2024-02-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008372-004ACTHAR GEL (AUTOINJECTOR)80 UNITS/MLINJECTABLE / INJECTIONRLD, RS2024-02-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008372-006ACTHAR GEL40 UNITS/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N008372-008ACTHAR GEL80 UNITS/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36862024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36872024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-003117521992041-07-18U-36882024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36862024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36872024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-004117521992041-07-18U-36882024-07-31c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36862023-09-21c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36872023-09-21c2088c7a36db…
2026-10-15 13:18:302026-09N008372-008117521992041-07-18U-36882023-09-21c2088c7a36db…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36862024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36872024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-003117521992041-07-18U-36882024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36862024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36872024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-004117521992041-07-18U-36882024-07-3184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36862023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36872023-09-2184e616aacf4f…
2026-09-14 22:38:342026-08N008372-008117521992041-07-18U-36882023-09-2184e616aacf4f…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36862024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36872024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-003117521992041-07-18U-36882024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36862024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36872024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-004117521992041-07-18U-36882024-07-31caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36862023-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36872023-09-21caaa826d4ba7…
2026-08-18 06:07:402026-07N008372-008117521992041-07-18U-36882023-09-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36862024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36872024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-003117521992041-07-18U-36882024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36862024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36872024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-004117521992041-07-18U-36882024-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36862023-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36872023-09-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N008372-008117521992041-07-18U-36882023-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36862024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36872024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-003117521992041-07-18U-36882024-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N008372-004117521992041-07-18U-36862024-07-3131067a03dcf5…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActharREPOSITORY CORTICOTROPINMallinckrodt ARD LLC7b48ddec-e815-45f4-9ca0-5c0daaf56f302026-07-15Warnings, Adverse reactionsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent
63004-8710ActharRepository CorticotropinMallinckrodt ARD LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77683SUPPL 2024-03-01
77681SUPPL 2024-03-01
77680SUPPL 2024-03-01
73595SUPPL 2023-02-23
69179SUPPL2021-11-01
69173SUPPL2021-10-29
69172SUPPL2021-10-29
66472SUPPL2021-03-03
66471SUPPL2021-03-03
66460SUPPL2021-03-03
58092SUPPL2019-03-27
58081SUPPL2019-03-27
53889SUPPL2018-05-01
53826SUPPL2018-04-27
32963SUPPL2015-05-08
150SUPPL2015-03-25
98SUPPL2012-07-09