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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065001
Company: FRESENIUS KABI USA
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 Discontinued None No No
CEFUROXIME SODIUM CEFUROXIME SODIUM EQ 1.5GM BASE/VIAL INJECTABLE;INJECTION Discontinued None 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
05/30/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65001ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2011 SUPPL-6 Labeling

Label is not available on this site.

02/20/2004 SUPPL-4 Labeling

Label is not available on this site.

11/12/2002 SUPPL-2 Labeling

Label is not available on this site.

03/28/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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