Last Updated: September 23, 2026

Details for New Drug Application (NDA): 077493

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NDA 077493 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-eight suppliers. Additional details are available on the RISPERIDONE profile page.

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

Summary for 077493

Tradename:	RISPERIDONE
Applicant:	Prinston Inc
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 077493

Medical Subject Heading (MeSH) Categories for 077493

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 077493

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET;ORAL	077493	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8196	0615-8196-05	15 TABLET in 1 BLISTER PACK (0615-8196-05)
RISPERIDONE	risperidone	TABLET;ORAL	077493	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8196	0615-8196-39	30 TABLET in 1 BLISTER PACK (0615-8196-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Nov 29, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 29, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Nov 29, 2011	TE:	AB	RLD:	No

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