Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076802
Company: TEVA

Products on ANDA 076802

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GLIMEPIRIDE	GLIMEPIRIDE	1MG	TABLET;ORAL	Discontinued	None	No	No
GLIMEPIRIDE	GLIMEPIRIDE	2MG	TABLET;ORAL	Discontinued	None	No	No
GLIMEPIRIDE	GLIMEPIRIDE	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076802

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2005	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076802ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076802Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/31/2019	SUPPL-20	Labeling-Package Insert		Label is not available on this site.
04/17/2017	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/29/2016	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
07/31/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
11/30/2009	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/30/2009	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/30/2009	SUPPL-12	Labeling		Label is not available on this site.
03/23/2012	SUPPL-11	Labeling		Label is not available on this site.
12/26/2007	SUPPL-6	Labeling		Label is not available on this site.
12/19/2006	SUPPL-4	Labeling		Label is not available on this site.