Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076172
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE 500MG TABLET, EXTENDED RELEASE;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
06/16/2004 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
02/26/2019 SUPPL-27 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

02/26/2019 SUPPL-25 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

10/31/2008 SUPPL-13 Labeling

Label is not available on this site.

05/25/2007 SUPPL-6 Labeling

Label is not available on this site.

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