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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 008372


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NDA 008372 describes ACTHAR GEL (AUTOINJECTOR), which is a drug marketed by Mallinckrodt Ard and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ACTHAR GEL (AUTOINJECTOR) profile page.

The generic ingredient in ACTHAR GEL (AUTOINJECTOR) is corticotropin. There are ten drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
Summary for 008372
Tradename:ACTHAR GEL (AUTOINJECTOR)
Applicant:Mallinckrodt Ard
Ingredient:corticotropin
Patents:1
Pharmacology for NDA: 008372
Suppliers and Packaging for NDA: 008372
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTHAR GEL corticotropin INJECTABLE;INJECTION 008372 NDA Mallinckrodt ARD LLC 63004-8710 63004-8710-1 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE
ACTHAR GEL (AUTOINJECTOR) corticotropin INJECTABLE;INJECTION 008372 NDA Mallinckrodt ARD LLC 63004-8710 63004-8710-1 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-1) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40 UNITS/0.5ML
Approval Date:Feb 29, 2024TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Feb 25, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF EXACERBATIONS OF MULTIPLE SCLEROSIS IN ADULTS WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING
Patent:⤷  Sign UpPatent Expiration:Feb 25, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFANTILE SPASMS WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING
Patent:⤷  Sign UpPatent Expiration:Feb 25, 2041Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPHTHALMIC DISEASES WITH CORTICOTROPIN BY PROMOTING NEW VESSEL FORMATION WHEREIN VCAM-1 EXPRESSION AND ANGIOPOETIN-2 EXPRESSION IS INCREASED AFTER THE ADMINISTERING

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