Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 211149

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

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: PALIPERIDONE PALMITATE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 39MG/0.25ML (39MG/0.25ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211149
Product Number: 001
Approval Date: Jul 6, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: PALIPERIDONE PALMITATE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 78MG/0.5ML (78MG/0.5ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211149
Product Number: 002
Approval Date: Jul 6, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: PALIPERIDONE PALMITATE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 117MG/0.75ML (117MG/0.75ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211149
Product Number: 003
Approval Date: Jul 6, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

PALIPERIDONE PALMITATE (PALIPERIDONE PALMITATE)
156MG/ML (156MG/ML)
Marketing Status: Discontinued

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: PALIPERIDONE PALMITATE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 156MG/ML (156MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211149
Product Number: 004
Approval Date: Jul 6, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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

Active Ingredient: PALIPERIDONE PALMITATE
Proprietary Name: PALIPERIDONE PALMITATE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR
Strength: 234MG/1.5ML (156MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A211149
Product Number: 005
Approval Date: Jul 6, 2021
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information