Details for New Drug Application (NDA): 050484
✉ Email this page to a colleague
NDA 050484 describes CERUBIDINE, which is a drug marketed by Hikma, Sanofi Aventis Us, and Wyeth Ayerst, and is included in three NDAs. Additional details are available on the CERUBIDINE profile page.
The generic ingredient in CERUBIDINE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
The generic ingredient in CERUBIDINE is daunorubicin hydrochloride. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the daunorubicin hydrochloride profile page.
Summary for 050484
| Tradename: | CERUBIDINE |
| Applicant: | Wyeth Ayerst |
| Ingredient: | daunorubicin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
