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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 021444

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NDA 021444 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from three suppliers. Additional details are available on the RISPERDAL profile page.

The generic ingredient in RISPERDAL 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 021444

Tradename:	RISPERDAL
Applicant:	Janssen Pharms
Ingredient:	risperidone
Patents:	0

Pharmacology for NDA: 021444

Medical Subject Heading (MeSH) Categories for 021444

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 2, 2003	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 2, 2003	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 2, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021444

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004	6,224,905*PED	⤷ Get Started Free
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-005	Dec 23, 2004	4,804,663*PED	⤷ Get Started Free
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003	6,224,905*PED	⤷ Get Started Free
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-004	Dec 23, 2004	6,224,905*PED	⤷ Get Started Free
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-003	Apr 2, 2003	6,244,905*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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