Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062984
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXACILLIN SODIUM OXACILLIN SODIUM EQ 10GM 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
09/29/1988 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
04/04/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

12/08/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/29/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/22/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/22/1997 SUPPL-11 Labeling

Label is not available on this site.

02/10/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/13/1994 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

11/19/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/19/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/11/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/18/1994 SUPPL-3 Labeling

Label is not available on this site.

11/09/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/07/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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