An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076995
Company: ACTAVIS LABS FL INC

Products on ANDA 076995

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 076995

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2010	ORIG-1	Approval				Label is not available on this site.

Top