Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213586

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UZEDY (RISPERIDONE)
50MG/0.14ML (50MG/0.14ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 50MG/0.14ML (50MG/0.14ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 001
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
75MG/0.21ML (75MG/0.21ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 75MG/0.21ML (75MG/0.21ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 002
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
100MG/0.28ML (100MG/0.28ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 100MG/0.28ML (100MG/0.28ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 003
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
125MG/0.35ML (125MG/0.35ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 125MG/0.35ML (125MG/0.35ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 004
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
150MG/0.42ML (150MG/0.42ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 150MG/0.42ML (150MG/0.42ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 005
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
200MG/0.56ML (200MG/0.56ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 200MG/0.56ML (200MG/0.56ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N213586
Product Number: 006
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

UZEDY (RISPERIDONE)
250MG/0.7ML (250MG/0.7ML)
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: UZEDY
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 250MG/0.7ML (250MG/0.7ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213586
Product Number: 007
Approval Date: Apr 28, 2023
Applicant Holder Full Name: TEVA NEUROSCIENCE INC
Marketing Status:  Prescription
Patent and Exclusivity Information