Product Details for ANDA 205618
PALIPERIDONE (PALIPERIDONE)
1.5MG
Marketing Status: Prescription
3MG
Marketing Status: Prescription
6MG
Marketing Status: Prescription
9MG
Marketing Status: Prescription
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: A205618
Product Number: 001
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PALIPERIDONE (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: A205618
Product Number: 001
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A205618
Product Number: 002
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PALIPERIDONE (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: A205618
Product Number: 002
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A205618
Product Number: 003
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
PALIPERIDONE (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: A205618
Product Number: 003
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A205618
Product Number: 004
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information
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: A205618
Product Number: 004
Approval Date: Apr 6, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status: Prescription
Patent and Exclusivity Information