Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065224
Company: BAXTER HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE IN PLASTIC CONTAINER CEFTRIAXONE SODIUM EQ 20MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
CEFTRIAXONE IN PLASTIC CONTAINER CEFTRIAXONE SODIUM EQ 40MG 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
08/23/2005 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
08/30/2013 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

06/18/2009 SUPPL-7 Labeling

Label is not available on this site.

03/05/2008 SUPPL-6 Labeling

Label is not available on this site.

09/12/2007 SUPPL-4 Labeling

Label is not available on this site.

10/22/2007 SUPPL-3 Labeling

Label is not available on this site.

04/24/2007 SUPPL-2 Labeling

Label is not available on this site.

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