Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065180
Company: WOCKHARDT
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 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
05/12/2006 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
09/11/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

09/11/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

03/02/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

03/02/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/20/2012 SUPPL-4 Labeling-Package Insert

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

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