Details for New Drug Application (NDA): 008372
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The generic ingredient in ACTHAR GEL 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 |
Applicant: | Mallinckrodt Ard |
Ingredient: | corticotropin |
Patents: | 1 |
Formulation / Manufacturing: | see details |
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 | corticotropin | INJECTABLE;INJECTION | 008372 | NDA | Mallinckrodt ARD LLC | 63004-8710 | 63004-8710-2 | 1 VIAL, MULTI-DOSE in 1 CARTON (63004-8710-2) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 006
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 40 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No |
Profile for product number 008
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80 UNITS/ML | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 25, 2041 | Product 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: | ⤷ Try a Trial | Patent Expiration: | Feb 25, 2041 | Product 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 |
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