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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 three patents protecting this drug. Additional details are available on the INVEGA profile page.

The generic ingredient in INVEGA is paliperidone palmitate. There are thirty-three 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 NDA: 021999

Tradename:
INVEGA
Applicant:
Janssen Pharms
Ingredient:
paliperidone
Patents:0
Therapeutic Class:Antipsychotics
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Dec 19, 2006TE:ABRLD:No

Summary for product number 002

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

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength9MG
Approval Date:Dec 19, 2006TE:ABRLD:No

Expired Orange Book 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;ORAL021999-006Aug 26, 20085,158,952*PED► subscribe
Janssen Pharms
INVEGA
paliperidone
TABLET, EXTENDED RELEASE;ORAL021999-003Dec 19, 20065,158,952*PED► subscribe
Janssen Pharms
INVEGA
paliperidone
TABLET, EXTENDED RELEASE;ORAL021999-004Dec 19, 20065,158,952*PED► subscribe
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