Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075978
Company: HERITAGE PHARMA
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
01/25/2002 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
02/22/2019 SUPPL-34 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/22/2019 SUPPL-33 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

03/19/2009 SUPPL-27 Labeling

Label is not available on this site.

03/12/2009 SUPPL-26 Labeling

Label is not available on this site.

06/30/2012 SUPPL-19 Labeling

Label is not available on this site.

04/18/2007 SUPPL-9 Labeling

Label is not available on this site.

01/03/2007 SUPPL-8 Labeling

Label is not available on this site.

08/06/2004 SUPPL-7 Labeling

Label is not available on this site.

01/02/2003 SUPPL-5 Labeling

Label is not available on this site.

11/05/2002 SUPPL-4 Labeling

Label is not available on this site.

09/04/2002 SUPPL-2 Labeling

Label is not available on this site.

11/05/2002 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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