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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 218586

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NDA 218586 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 218586

Tradename:	RISPERIDONE
Applicant:	Amneal
Ingredient:	risperidone
Patents:	0

Medical Subject Heading (MeSH) Categories for 218586

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 218586

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERIDONE	risperidone	POWDER;INTRAMUSCULAR	218586	ANDA	Amneal Pharmaceuticals LLC	70121-2625	70121-2625-5	1 KIT in 1 CARTON (70121-2625-5) * 2 mL in 1 VIAL (70121-1350-1) * 2 mL in 1 SYRINGE (70121-2624-2)
RISPERIDONE	risperidone	POWDER;INTRAMUSCULAR	218586	ANDA	Amneal Pharmaceuticals LLC	70121-2626	70121-2626-5	1 KIT in 1 CARTON (70121-2626-5) * 2 mL in 1 SYRINGE (70121-2624-2) * 2 mL in 1 VIAL (70121-1351-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	12.5MG/VIAL
Approval Date:	Sep 2, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	25MG/VIAL
Approval Date:	Sep 2, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	37.5MG/VIAL
Approval Date:	Sep 2, 2025	TE:	AB	RLD:	No

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