Details for New Drug Application (NDA): 008317
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NDA 008317 describes ACTH, which is a drug marketed by Parkedale, Sanofi Aventis Us, and Mallinckrodt Ireland, and is included in three NDAs. There is one patent protecting this drug. Additional details are available on the ACTH profile page.
The generic ingredient in ACTH 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 ACTH 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 008317
| Tradename: | ACTH |
| Applicant: | Parkedale |
| 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 004
| 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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