Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075976
Company: PHARMOBEDIENT

Products on ANDA 075976

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 075976

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.