CEFUROXIME SODIUM از شرکت ACS DOBFAR SPA

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CEFUROXIME SODIUM از شرکت ACS DOBFAR SPA

Abbreviated New Drug Application (ANDA): 064125

Company: ACS DOBFAR SPA

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE;INTRAMUSCULAR, INTRAVENOUSPrescription

AB

NoNo
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE;INJECTIONPrescription

AP

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
05/30/1997ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
04/12/2016SUPPL-9 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

01/31/2007SUPPL-5 Labeling

Label is not available on this site.

08/23/2004SUPPL-3 Labeling

Label is not available on this site.

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

Label is not available on this site.

CEFUROXIME SODIUM

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS; EQ 750MG BASE/VIAL

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE;INTRAMUSCULAR, INTRAVENOUSPrescriptionNoAB064125ACS DOBFAR SPA
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE;INTRAMUSCULAR, INTRAVENOUSPrescriptionNoAB065048HIKMA FARMACEUTICA
ZINACEFCEFUROXIME SODIUMEQ 750MG BASE/VIALINJECTABLE;INTRAMUSCULAR, INTRAVENOUSPrescriptionYesAB050558TELIGENT

INJECTABLE;INJECTION; EQ 1.5GM BASE/VIAL

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINERCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionYesAP050780B BRAUN
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP064125ACS DOBFAR SPA
CEFUROXIME SODIUMCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionNoAP065048HIKMA FARMACEUTICA
ZINACEFCEFUROXIME SODIUMEQ 1.5GM BASE/VIALINJECTABLE;INJECTIONPrescriptionYesAP050558TELIGENT
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