Details for New Drug Application (NDA): 061876
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NDA 061876 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 061876
| Tradename: | CERUBIDINE |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | daunorubicin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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