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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078812
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXALIPLATIN OXALIPLATIN 50MG/10ML (5MG/ML) INJECTABLE;INTRAVENOUS Discontinued None No No
OXALIPLATIN OXALIPLATIN 100MG/20ML (5MG/ML) INJECTABLE;INTRAVENOUS 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
08/07/2009 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
09/10/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

09/10/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

02/28/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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