Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064125
Company: ACS DOBFAR SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription AB No No
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM 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
05/30/1997 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
04/12/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

11/21/2012 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

01/31/2007 SUPPL-5 Labeling

Label is not available on this site.

08/23/2004 SUPPL-3 Labeling

Label is not available on this site.

09/23/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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 FARMACEUTICA
ZINACEF CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Prescription Yes AB 050558 TELIGENT

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 AND DEXTROSE IN DUPLEX CONTAINER CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050780 B BRAUN
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 FARMACEUTICA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065483 HOSPIRA INC
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065503 HOSPIRA INC
ZINACEF CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 TELIGENT

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