Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075978
Company: HERITAGE PHARMA

Products on ANDA 075978

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 075978

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.