Last Updated: November 8, 2026

Details for New Drug Application (NDA): 021346

NDA 021346 describes RISPERDAL CONSTA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the RISPERDAL CONSTA profile page.

The generic ingredient in RISPERDAL CONSTA is risperidone. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the risperidone profile page.

Summary for 021346

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

Medical Subject Heading (MeSH) Categories for 021346

Antipsychotic Agents
Dopamine Antagonists
Serotonin Antagonists

Suppliers and Packaging for NDA: 021346

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346	NDA	Janssen Pharmaceuticals, Inc.	50458-306	50458-306-11	1 KIT in 1 BOX (50458-306-11) * 2 mL in 1 SYRINGE (50458-306-01) * 2 mL in 1 VIAL
RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346	NDA	Janssen Pharmaceuticals, Inc.	50458-307	50458-307-11	1 KIT in 1 BOX (50458-307-11) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE (50458-307-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	25MG/VIAL
Approval Date:	Oct 29, 2003	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	37.5MG/VIAL
Approval Date:	Oct 29, 2003	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	50MG/VIAL
Approval Date:	Oct 29, 2003	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021346

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-001	Oct 29, 2003	⤷ Start Trial	⤷ Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-003	Oct 29, 2003	⤷ Start Trial	⤷ Start Trial
Janssen Pharms	RISPERDAL CONSTA	risperidone	POWDER;INTRAMUSCULAR	021346-002	Oct 29, 2003	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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