Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 065204
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No Yes
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
05/03/2005 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
03/05/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/05/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

03/05/2016 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/13/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/31/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/14/2009 SUPPL-3 Labeling

Label is not available on this site.

CEFTRIAXONE

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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