Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216352

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ERZOFRI (PALIPERIDONE PALMITATE)
39MG/0.25ML (39MG/0.25ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 39MG/0.25ML (39MG/0.25ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 001
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ERZOFRI (PALIPERIDONE PALMITATE)
78MG/0.5ML (78MG/0.5ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 78MG/0.5ML (78MG/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 002
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ERZOFRI (PALIPERIDONE PALMITATE)
117MG/0.75ML (117MG/0.75ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 117MG/0.75ML (117MG/0.75ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 003
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ERZOFRI (PALIPERIDONE PALMITATE)
156MG/ML (156MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 156MG/ML (156MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 004
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ERZOFRI (PALIPERIDONE PALMITATE)
234MG/1.5ML (156MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 234MG/1.5ML (156MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 005
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ERZOFRI (PALIPERIDONE PALMITATE)
351MG/2.25ML (156MG/ML)
Marketing Status: Prescription

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: ERZOFRI
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 351MG/2.25ML (156MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216352
Product Number: 006
Approval Date: Jul 26, 2024
Applicant Holder Full Name: LUYE INNOMIND PHARMA (SHIJIAZHUANG) CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information