Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061490
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXACILLIN SODIUM OXACILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
OXACILLIN SODIUM OXACILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
OXACILLIN SODIUM OXACILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
OXACILLIN SODIUM OXACILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
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
04/08/1971 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
04/11/2016 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

04/11/2016 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

03/27/2012 SUPPL-35 Labeling-Container/Carton Labels

Label is not available on this site.

12/02/2014 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

04/11/2016 SUPPL-32 Labeling

Label is not available on this site.

10/04/2004 SUPPL-25 Labeling

Label is not available on this site.

10/04/2004 SUPPL-24 Labeling

Label is not available on this site.

10/04/2004 SUPPL-23 Labeling

Label is not available on this site.

05/09/1991 SUPPL-20 Labeling

Label is not available on this site.

12/22/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

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