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Last Updated: November 14, 2019

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Details for New Drug Application (NDA): 207946

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NDA 207946 describes INVEGA TRINZA, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the INVEGA TRINZA profile page.

The generic ingredient in INVEGA TRINZA 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 207946
Tradename:INVEGA TRINZA
Applicant:Janssen Pharms
Ingredient:paliperidone palmitate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 207946
Suppliers and Packaging for NDA: 207946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946 NDA Janssen Pharmaceuticals, Inc 50458-606 50458-606-01 1 SYRINGE in 1 KIT (50458-606-01) > 1 mL in 1 SYRINGE
INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946 NDA Janssen Pharmaceuticals, Inc 50458-607 50458-607-01 1 SYRINGE in 1 KIT (50458-607-01) > 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength273MG/0.875ML (273MG/0.875ML)
Approval Date:May 18, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 5, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Patent:  Start TrialPatent Expiration:Apr 5, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength410MG/1.315ML (311.79MG/ML)
Approval Date:May 18, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 5, 2036Product Flag?Substance Flag?Delist Request?
Patented Use:REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO

Expired US Patents for NDA 207946

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-004 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-001 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-002 May 18, 2015   Start Trial   Start Trial
Janssen Pharms INVEGA TRINZA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-003 May 18, 2015   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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