Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078071

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RISPERIDONE (RISPERIDONE)
0.25MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 001
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERIDONE (RISPERIDONE)
0.5MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 002
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERIDONE (RISPERIDONE)
1MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 003
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERIDONE (RISPERIDONE)
2MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 004
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERIDONE (RISPERIDONE)
3MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 005
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RISPERIDONE (RISPERIDONE)
4MG
Marketing Status: Prescription

Active Ingredient: RISPERIDONE
Proprietary Name: RISPERIDONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078071
Product Number: 006
Approval Date: Jun 17, 2009
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information