Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064103
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CERUBIDINE DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/03/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1999 SUPPL-9 Labeling

Label is not available on this site.

02/18/1999 SUPPL-8 Labeling

Label is not available on this site.

11/19/1999 SUPPL-7 Labeling

Label is not available on this site.

11/19/1999 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/19/1999 SUPPL-3 Manufacturing (CMC)-New Strength

Label is not available on this site.

09/03/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CERUBIDINE

INJECTABLE;INJECTION; EQ 20MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CERUBIDINE DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064103 WEST-WARD PHARMS INT
DAUNORUBICIN HYDROCHLORIDE DAUNORUBICIN HYDROCHLORIDE EQ 20MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065000 FRESENIUS KABI USA

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