Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091537
Company: NATCO PHARMA USA

Products on ANDA 091537

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091537

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2011	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
11/02/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/02/2023	SUPPL-11	Labeling-Patient Package Insert		Label is not available on this site.
10/28/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/28/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
11/28/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
12/13/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/22/2013	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
02/12/2013	SUPPL-2	Manufacturing (CMC)-New Strength		Label is not available on this site.
02/13/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.