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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076866
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OLANZAPINE OLANZAPINE 2.5MG TABLET;ORAL Discontinued None No No
OLANZAPINE OLANZAPINE 5MG TABLET;ORAL Discontinued None No No
OLANZAPINE OLANZAPINE 7.5MG TABLET;ORAL Discontinued None No No
OLANZAPINE OLANZAPINE 10MG TABLET;ORAL Discontinued None No No
OLANZAPINE OLANZAPINE 15MG TABLET;ORAL Discontinued None No No
OLANZAPINE OLANZAPINE 20MG TABLET;ORAL 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
04/23/2012 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
09/25/2015 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/25/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

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