Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207946

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INVEGA HAFYERA (PALIPERIDONE PALMITATE)
1.092GM/3.5ML (312MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA HAFYERA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 1.092GM/3.5ML (312MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207946
Product Number: 005
Approval Date: Aug 30, 2021
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA HAFYERA (PALIPERIDONE PALMITATE)
1.560GM/5ML (312MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA HAFYERA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 1.560GM/5ML (312MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207946
Product Number: 006
Approval Date: Aug 30, 2021
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA TRINZA (PALIPERIDONE PALMITATE)
273MG/0.875ML (273MG/0.875ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA TRINZA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 273MG/0.875ML (273MG/0.875ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207946
Product Number: 001
Approval Date: May 18, 2015
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA TRINZA (PALIPERIDONE PALMITATE)
410MG/1.315ML (311.79MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA TRINZA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 410MG/1.315ML (311.79MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207946
Product Number: 002
Approval Date: May 18, 2015
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA TRINZA (PALIPERIDONE PALMITATE)
546MG/1.75ML (312MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA TRINZA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 546MG/1.75ML (312MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207946
Product Number: 003
Approval Date: May 18, 2015
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

INVEGA TRINZA (PALIPERIDONE PALMITATE)
819MG/2.625ML (312MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: INVEGA TRINZA
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 819MG/2.625ML (312MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207946
Product Number: 004
Approval Date: May 18, 2015
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information