Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077624
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLIMEPIRIDE GLIMEPIRIDE 1MG TABLET;ORAL Discontinued None No No
GLIMEPIRIDE GLIMEPIRIDE 2MG TABLET;ORAL Discontinued None No No
GLIMEPIRIDE GLIMEPIRIDE 4MG 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
11/28/2005 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
05/31/2019 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/17/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

04/26/2016 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/19/2009 SUPPL-3 Labeling

Label is not available on this site.

10/01/2007 SUPPL-1 Labeling

Label is not available on this site.

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