Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 063002
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANCEF IN PLASTIC CONTAINER CEFAZOLIN SODIUM EQ 10MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
ANCEF IN PLASTIC CONTAINER CEFAZOLIN SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Prescription None 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
03/28/1991 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
02/29/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

03/22/2013 SUPPL-10 Labeling

Label is not available on this site.

04/30/2008 SUPPL-7 Labeling

Label is not available on this site.

10/07/2004 SUPPL-6 Labeling

Label is not available on this site.

03/06/2001 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/27/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/21/1992 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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