Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078740
Company: WEST WARD PHARMS

Products on ANDA 078740

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RISPERIDONE	RISPERIDONE	0.25MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	0.5MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	1MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	2MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	3MG	TABLET;ORAL	Discontinued	None	No	No
RISPERIDONE	RISPERIDONE	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078740

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/2009	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
09/12/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
09/12/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/21/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/21/2020	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/31/2012	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/08/2011	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/15/2011	SUPPL-3	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
02/04/2010	SUPPL-1	Labeling-Package Insert		Label is not available on this site.