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.
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 |
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 | |||||
| Patent: | 11,752,199 | 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: | 11,752,199 | 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 | ||||||||
| Patent: | 11,752,199 | Patent Expiration: | Feb 25, 2041 | Product 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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