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Generated: November 21, 2018

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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 five suppliers. There are two 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
Formulation / Manufacturing:see details
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 Patriot Pharmaceuticals, LLC 10147-0951 10147-0951-3 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10147-0951-3)
INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999 NDA Patriot Pharmaceuticals, LLC 10147-0952 10147-0952-1 10 BLISTER PACK in 1 BOX, UNIT-DOSE (10147-0952-1) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Dec 19, 2006TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Dec 19, 2006TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Dec 19, 2006TE:ABRLD:Yes

Expired US Patents for NDA 021999

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 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-003 Dec 19, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-004 Dec 19, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-002 Dec 19, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Pharms INVEGA paliperidone TABLET, EXTENDED RELEASE;ORAL 021999-001 Dec 19, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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