Details for New Drug Application (NDA): 008372
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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 |
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 (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: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40 UNITS/0.5ML | ||||
Approval Date: | Feb 29, 2024 | TE: | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 80 UNITS/ML | ||||
Approval Date: | Feb 29, 2024 | TE: | RLD: | Yes |
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 |
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