Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076731
Company: IMPAX LABS INC

Products on ANDA 076731

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG	TABLET;ORAL	Discontinued	None	No	No
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG	TABLET;ORAL	Discontinued	None	No	No
GLYBURIDE AND METFORMIN HYDROCHLORIDE	GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076731

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/19/2004	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
05/08/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/18/2011	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
09/30/2010	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/13/2010	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/18/2009	SUPPL-10	Labeling		Label is not available on this site.
07/03/2006	SUPPL-1	Labeling		Label is not available on this site.