Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075979
Company: WATSON LABS
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
03/04/2005 SUPPL-10 Labeling

Label is not available on this site.

04/01/2004 SUPPL-9 Labeling

Label is not available on this site.

08/13/2002 SUPPL-6 Labeling

Label is not available on this site.

10/11/2002 SUPPL-5 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

04/22/2002 SUPPL-4 Labeling

Label is not available on this site.

02/27/2003 SUPPL-3 Labeling

Label is not available on this site.

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