Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076802
Company: TEVA
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
10/06/2005 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076802ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076802Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2019 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

04/17/2017 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

02/29/2016 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/30/2009 SUPPL-12 Labeling

Label is not available on this site.

03/23/2012 SUPPL-11 Labeling

Label is not available on this site.

12/26/2007 SUPPL-6 Labeling

Label is not available on this site.

12/19/2006 SUPPL-4 Labeling

Label is not available on this site.

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