Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064036
Company: WATSON LABS INC
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 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-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/23/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

07/15/1997 SUPPL-15 Labeling

Label is not available on this site.

08/20/1997 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.

10/04/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/06/1996 SUPPL-11 Labeling

Label is not available on this site.

07/03/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-9 Labeling

Label is not available on this site.

10/27/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/17/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

12/13/1994 SUPPL-5 Labeling

Label is not available on this site.

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

Label is not available on this site.

03/15/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/26/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/20/1993 SUPPL-1 Labeling

Label is not available on this site.

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