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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065169
Company: SANDOZ

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No Yes
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No Yes
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No Yes
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
05/09/2005 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
01/13/2022 SUPPL-35 Labeling-Package Insert

Label is not available on this site.
03/05/2016 SUPPL-26 Labeling-Package Insert

Label is not available on this site.
03/05/2016 SUPPL-25 Labeling-Package Insert

Label is not available on this site.
02/05/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/065169Orig1s022ltr.pdf
07/13/2011 SUPPL-18 Labeling-Package Insert

Label is not available on this site.
11/24/2010 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.
06/05/2009 SUPPL-8 Labeling

Label is not available on this site.
01/14/2009 SUPPL-6 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/05/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065169s022lbl.pdf

CEFTRIAXONE

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 250MG 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 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 210197 DEVA HOLDING AS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065305 EPIC PHARMA LLC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065342 HIKMA FARMACEUTICA
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 203702 QILU
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065169 SANDOZ
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065391 WOCKHARDT

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 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;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 210197 DEVA HOLDING AS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065305 EPIC PHARMA LLC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065342 HIKMA FARMACEUTICA
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 203702 QILU
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065169 SANDOZ
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065391 WOCKHARDT

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 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;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 210197 DEVA HOLDING AS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065305 EPIC PHARMA LLC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065342 HIKMA FARMACEUTICA
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 203702 QILU
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065169 SANDOZ

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; 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;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 210197 DEVA HOLDING AS
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065305 EPIC PHARMA LLC
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065342 HIKMA FARMACEUTICA
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 203702 QILU
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065169 SANDOZ
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AP 065391 WOCKHARDT
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