Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065329
Company: ACS DOBFAR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
07/24/2008 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
03/02/2016 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

11/07/2014 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/02/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/29/2010 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

01/24/2010 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

10/15/2009 SUPPL-1 Labeling

Label is not available on this site.

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065329 ACS DOBFAR

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065329 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065204 SANDOZ INC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065180 WOCKHARDT
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050796 B BRAUN

INJECTABLE;INJECTION; EQ 2GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065329 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065204 SANDOZ INC
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050796 B BRAUN

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