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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065048
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME CEFUROXIME 1.5G/20ML Injectable; Injection Prescription None No No
CEFUROXIME CEFUROXIME 1.5G/100ML Injectable; Injection Prescription None No No
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AB No Yes
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM 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
01/09/2004 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
07/07/2021 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

07/07/2021 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

11/16/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

04/12/2016 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/16/2008 SUPPL-8 Labeling

Label is not available on this site.

CEFUROXIME

There are no Therapeutic Equivalents.

CEFUROXIME SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AB 064125 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription No AB 065048 HIKMA

INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064125 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065048 HIKMA
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