Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062590
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KEFUROX IN PLASTIC CONTAINER CEFUROXIME SODIUM EQ 750MG BASE/VIAL INJECTABLE;INTRAVENOUS Discontinued None No No
KEFUROX IN PLASTIC CONTAINER 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
01/10/1986 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
04/14/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/12/1992 SUPPL-8 Labeling

Label is not available on this site.

06/12/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/09/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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