Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064124
Company: ACS DOBFAR SPA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM 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
07/31/2008 SUPPL-8 Labeling

Label is not available on this site.

11/16/2007 SUPPL-7 Labeling

Label is not available on this site.

06/20/2007 SUPPL-6 Labeling

Label is not available on this site.

01/31/2007 SUPPL-5 Labeling

Label is not available on this site.

09/30/2004 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;INJECTION; EQ 7.5GM 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 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 064124 ACS DOBFAR SPA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065046 HIKMA FARMACEUTICA
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065484 HOSPIRA INC
ZINACEF CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 TELIGENT

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