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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064035
Company: WATSON LABS INC
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
02/26/1993 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
12/08/2000 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/23/1998 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

08/20/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/10/1996 SUPPL-12 Labeling

Label is not available on this site.

07/02/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-10 Labeling

Label is not available on this site.

10/26/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-6 Labeling

Label is not available on this site.

03/15/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/15/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/17/1993 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/20/1993 SUPPL-2 Labeling

Label is not available on this site.

08/13/1993 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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