Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 071471
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTARABINE CYTARABINE 100MG/VIAL INJECTABLE;INJECTION Prescription 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
08/02/1989 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
06/18/2004 SUPPL-11 Labeling

Label is not available on this site.

10/13/2000 SUPPL-7 Labeling

Label is not available on this site.

07/11/1997 SUPPL-6 Labeling

Label is not available on this site.

07/21/1995 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/17/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/09/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/30/1992 SUPPL-2 Labeling

Label is not available on this site.

12/18/1990 SUPPL-1 Labeling

Label is not available on this site.

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