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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-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: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength273MG/0.875ML (273MG/0.875ML)
Approval Date:May 18, 2015TE:RLD:No
Patent:6,077,843*PEDPatent Expiration:Nov 12, 2017Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:May 18, 2018
Regulatory Exclusivity Use:NEW PRODUCT

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength410MG/1.315ML (311.79MG/ML)
Approval Date:May 18, 2015TE:RLD:No
Patent:6,077,843*PEDPatent Expiration:Nov 12, 2017Product Flag?Substance Flag?Delist Request?Y


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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