Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065168
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM 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
05/17/2005 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-23 Labeling-Package Insert

Label is not available on this site.

03/05/2016 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

01/31/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf
02/17/2012 SUPPL-15 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/23/2010 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

01/14/2009 SUPPL-5 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/31/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065168s019lbl.pdf

CEFTRIAXONE

INJECTABLE;INJECTION; EQ 10GM 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 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065328 ACS DOBFAR
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 209218 QILU
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065168 SANDOZ
CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 091117 ASTRAL
CEFTRIAXONE SODIUM CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090701 HIKMA

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