Details for New Drug Application (NDA): 007504
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NDA 007504 describes ACTHAR, which is a drug marketed by Sanofi Aventis Us and Mallinckrodt Ard and is included in two NDAs. There is one patent protecting this drug. Additional details are available on the ACTHAR profile page.
The generic ingredient in ACTHAR is corticotropin. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
The generic ingredient in ACTHAR is corticotropin. There are ten drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the corticotropin profile page.
Summary for 007504
| Tradename: | ACTHAR |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | corticotropin |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 25 UNITS/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 40 UNITS/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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