Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075985
Company: SANDOZ

Products on ANDA 075985

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075985

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
06/21/2010	SUPPL-37	Labeling-Package Insert		Label is not available on this site.
08/20/2009	SUPPL-35	Labeling		Label is not available on this site.
10/09/2008	SUPPL-34	Labeling		Label is not available on this site.
01/28/2008	SUPPL-30	Labeling		Label is not available on this site.
05/12/2008	SUPPL-26	Labeling		Label is not available on this site.
01/27/2005	SUPPL-14	Labeling		Label is not available on this site.
08/13/2002	SUPPL-9	Labeling		Label is not available on this site.
04/11/2002	SUPPL-8	Labeling		Label is not available on this site.
08/29/2002	SUPPL-5	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
08/29/2002	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/2002	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
06/12/2002	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/12/2002	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.