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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078516

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NDA 078516 describes RISPERIDONE, which is a drug marketed by Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sciegen Pharms Inc, Taro, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Chartwell Rx, Dash Pharms, Dr Reddys Labs Ltd, Endo Operations, Jubilant Generics, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Esjay Pharma, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, 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-six NDAs. It is available from thirty-three 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 078516

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

Pharmacology for NDA: 078516

Medical Subject Heading (MeSH) Categories for 078516

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 078516

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	078516	ANDA	Zydus Lifesciences Limited	65841-640	65841-640-06	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-640-06)
RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	078516	ANDA	Zydus Lifesciences Limited	65841-641	65841-641-06	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-641-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.5MG
Approval Date:	May 1, 2009	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	2MG
Approval Date:	May 1, 2009	TE:	AB	RLD:	No

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