Last Updated: July 25, 2026

Details for New Drug Application (NDA): 078474

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NDA 078474 describes RISPERIDONE, which is a drug marketed by Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sun Pharma Canada, Tris Pharma Inc, Wockhardt Bio Ag, Actavis Labs Fl Inc, Chartwell Rx, Jubilant Generics, Natco Pharma Usa, Ph Health, Sandoz, Senores Pharms, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in forty-eight NDAs. It is available from thirty-six suppliers. Additional details are available on the RISPERIDONE profile page.

The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 078474

Tradename:	RISPERIDONE
Applicant:	Sun Pharm Inds Ltd
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 078474

Medical Subject Heading (MeSH) Categories for 078474

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 078474

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	078474	ANDA	Sun Pharmaceutical Industries, Inc.	63304-643	63304-643-05	500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-643-05)
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	078474	ANDA	Sun Pharmaceutical Industries, Inc.	63304-643	63304-643-17	10 POUCH in 1 BOX, UNIT-DOSE (63304-643-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-643-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	3MG
Approval Date:	Aug 6, 2010	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	4MG
Approval Date:	Aug 6, 2010	TE:	AB	RLD:	No

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