Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076866
Company: MYLAN

Products on ANDA 076866

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
OLANZAPINE	OLANZAPINE	20MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076866

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2012	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
08/08/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/08/2023	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/08/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/08/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/25/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.