Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075976
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET;ORAL Discontinued None No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 850MG TABLET;ORAL Discontinued None No No
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 1GM 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
01/24/2002 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
11/14/2019 SUPPL-21 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

11/14/2019 SUPPL-20 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

09/29/2010 SUPPL-17 Labeling

Label is not available on this site.

03/08/2007 SUPPL-14 Labeling

Label is not available on this site.

09/21/2004 SUPPL-8 Labeling

Label is not available on this site.

05/14/2004 SUPPL-7 Labeling

Label is not available on this site.

08/14/2003 SUPPL-4 Labeling

Label is not available on this site.

10/03/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

04/11/2002 SUPPL-1 Labeling

Label is not available on this site.

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