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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 020588

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NDA 020588 describes RISPERDAL, which is a drug marketed by Janssen Pharms and is included in four NDAs. It is available from four 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. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 020588

Tradename:	RISPERDAL
Applicant:	Janssen Pharms
Ingredient:	risperidone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020588

Medical Subject Heading (MeSH) Categories for 020588

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 020588

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERDAL	risperidone	SOLUTION;ORAL	020588	NDA	Janssen Pharmaceuticals, Inc.	50458-305	50458-305-03	30 mL in 1 BOTTLE (50458-305-03)
RISPERDAL	risperidone	SOLUTION;ORAL	020588	NDA	Janssen Pharmaceutical, Inc.	50458-596	50458-596-01	30 mL in 1 BOTTLE (50458-596-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Jun 10, 1996	TE:	AA	RLD:	Yes

Expired US Patents for NDA 020588

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	SOLUTION;ORAL	020588-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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