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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 079088

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NDA 079088 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, Dash Pharms, Jubilant Generics, 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-four 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. Thirty-nine suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 079088

Tradename:	RISPERIDONE
Applicant:	Torrent Pharms
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 079088

Medical Subject Heading (MeSH) Categories for 079088

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 079088

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET;ORAL	079088	ANDA	Torrent Pharmaceuticals Limited	13668-035	13668-035-01	100 TABLET in 1 BOTTLE (13668-035-01)
RISPERIDONE	risperidone	TABLET;ORAL	079088	ANDA	Torrent Pharmaceuticals Limited	13668-035	13668-035-05	500 TABLET in 1 BOTTLE (13668-035-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.25MG
Approval Date:	Oct 30, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Oct 30, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 30, 2008	TE:	AB	RLD:	No

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