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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065342
Company: HIKMA FARMACEUTICA

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 No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AP No No
CEFTRIAXONE CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 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
01/10/2008 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
01/13/2022 SUPPL-22 Labeling-Package Insert

Label is not available on this site.
09/11/2020 SUPPL-15 Labeling-Package Insert

Label is not available on this site.
09/11/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
08/29/2014 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
08/04/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
07/06/2010 SUPPL-7 Labeling-Package Insert

Label is not available on this site.
11/20/2009 SUPPL-4 Labeling

Label is not available on this site.

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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