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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204707

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PALIPERIDONE (PALIPERIDONE)
1.5MG
Marketing Status: Prescription
Active Ingredient: PALIPERIDONE
Proprietary Name: PALIPERIDONE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204707
Product Number: 001
Approval Date: Sep 23, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PALIPERIDONE (PALIPERIDONE)
3MG
Marketing Status: Prescription
Active Ingredient: PALIPERIDONE
Proprietary Name: PALIPERIDONE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204707
Product Number: 002
Approval Date: Sep 23, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PALIPERIDONE (PALIPERIDONE)
6MG
Marketing Status: Prescription
Active Ingredient: PALIPERIDONE
Proprietary Name: PALIPERIDONE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 6MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204707
Product Number: 003
Approval Date: Sep 23, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
PALIPERIDONE (PALIPERIDONE)
9MG
Marketing Status: Prescription
Active Ingredient: PALIPERIDONE
Proprietary Name: PALIPERIDONE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204707
Product Number: 004
Approval Date: Sep 23, 2019
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NEW YORK LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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