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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 020272

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NDA 020272 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 020272

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

Pharmacology for NDA: 020272

Medical Subject Heading (MeSH) Categories for 020272

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 020272

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERDAL	risperidone	TABLET;ORAL	020272	NDA	Aphena Pharma Solutions - Tennessee, LLC	43353-412	43353-412-15	15 TABLET in 1 BOTTLE (43353-412-15)
RISPERDAL	risperidone	TABLET;ORAL	020272	NDA	Aphena Pharma Solutions - Tennessee, LLC	43353-412	43353-412-30	30 TABLET in 1 BOTTLE (43353-412-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 29, 1993	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Dec 29, 1993	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Dec 29, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020272

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-007	Jan 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-001	Dec 29, 1993	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-004	Dec 29, 1993	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-003	Dec 29, 1993	⤷ Try a Trial	⤷ Try a Trial
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-001	Dec 29, 1993	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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