Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050484
Company: WYETH AYERST
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERUBIDINE DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/19/1979 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/01/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1993 SUPPL-5 Labeling

Label is not available on this site.

03/11/1992 SUPPL-4 Labeling

Label is not available on this site.

03/06/1987 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

12/03/1982 SUPPL-2 Labeling

Label is not available on this site.

02/26/1980 SUPPL-1 Labeling

Label is not available on this site.

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