Details for New Drug Application (NDA): 021999

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NDA 021999 describes INVEGA, which is a drug marketed by Janssen Pharms and is included in three NDAs. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INVEGA profile page.

The generic ingredient in INVEGA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

Summary for 021999

Tradename:	INVEGA
Applicant:	Janssen Pharms
Ingredient:	paliperidone
Patents:	0

Pharmacology for NDA: 021999

Suppliers and Packaging for NDA: 021999

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999	NDA	Janssen Pharmaceuticals, Inc.	50458-550	50458-550-01	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-01)
INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999	NDA	Janssen Pharmaceuticals, Inc.	50458-550	50458-550-98	7 TABLET, EXTENDED RELEASE in 1 BOTTLE (50458-550-98)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	3MG
Approval Date:	Dec 19, 2006	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	6MG
Approval Date:	Dec 19, 2006	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	9MG
Approval Date:	Dec 19, 2006	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021999

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-006	Aug 26, 2008	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-003	Dec 19, 2006	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-004	Dec 19, 2006	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-002	Dec 19, 2006	⤷ Sign Up	⤷ Sign Up
Janssen Pharms	INVEGA	paliperidone	TABLET, EXTENDED RELEASE;ORAL	021999-001	Dec 19, 2006	⤷ Sign Up	⤷ Sign Up
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