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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078040

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NDA 078040 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, Anda Repository, Chartwell Rx, Dash Pharms, Jubilant Generics, Ph Health, Sandoz, 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-five 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 suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 078040

Tradename:	RISPERIDONE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 078040

Medical Subject Heading (MeSH) Categories for 078040

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 078040

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET;ORAL	078040	ANDA	Major Pharmaceuticals	0904-7360	0904-7360-61	100 BLISTER PACK in 1 CARTON (0904-7360-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
RISPERIDONE	risperidone	TABLET;ORAL	078040	ANDA	Major Pharmaceuticals	0904-7361	0904-7361-61	100 BLISTER PACK in 1 CARTON (0904-7361-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Oct 16, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 16, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 16, 2008	TE:	AB	RLD:	No

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