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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065294
Company: CEPHAZONE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
03/26/2007 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
08/20/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/05/2008 SUPPL-2 Labeling

Label is not available on this site.

12/05/2008 SUPPL-1 Labeling

Label is not available on this site.

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