Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076000
Company: TEVA PHARMS

Products on ANDA 076000

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLANZAPINE	OLANZAPINE	2.5MG	TABLET;ORAL	Discontinued	None	No	No
OLANZAPINE	OLANZAPINE	5MG	TABLET;ORAL	Discontinued	None	No	No
OLANZAPINE	OLANZAPINE	7.5MG	TABLET;ORAL	Discontinued	None	No	No
OLANZAPINE	OLANZAPINE	10MG	TABLET;ORAL	Discontinued	None	No	No
OLANZAPINE	OLANZAPINE	15MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076000

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/24/2011	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
04/15/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/16/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.