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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065046
Company: HIKMA FARMACEUTICA
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
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-13 Labeling-Package Insert

Label is not available on this site.

07/07/2021 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

05/06/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/25/2008 SUPPL-3 Labeling

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
ZINACEF CEFUROXIME SODIUM EQ 7.5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050558 PAI HOLDINGS PHARM
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