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:	4

Pharmacology for NDA: 207946

Medical Subject Heading (MeSH) Categories for 207946

Antipsychotic Agents
Dopamine D2 Receptor Antagonists
Serotonin 5-HT2 Receptor Antagonists

Suppliers and Packaging for NDA: 207946

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INVEGA HAFYERA	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	50458-606	50458-606-01	1 SYRINGE in 1 KIT (50458-606-01) / 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	273MG/0.875ML (273MG/0.875ML)
Approval Date:	May 18, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 5, 2036	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO
Patent:	⤷ Sign Up	Patent Expiration:	Apr 5, 2036	Product 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:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	410MG/1.315ML (311.79MG/ML)
Approval Date:	May 18, 2015	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 5, 2036	Product 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

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

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