Product Details for ANDA 204111
ARIPIPRAZOLE (ARIPIPRAZOLE)
2MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
2MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 001
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ARIPIPRAZOLE (ARIPIPRAZOLE)
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 001
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 002
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ARIPIPRAZOLE (ARIPIPRAZOLE)
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 002
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 003
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ARIPIPRAZOLE (ARIPIPRAZOLE)
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 003
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
15MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 004
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ARIPIPRAZOLE (ARIPIPRAZOLE)
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 004
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 005
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
ARIPIPRAZOLE (ARIPIPRAZOLE)
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 005
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 006
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A204111
Product Number: 006
Approval Date: Oct 7, 2016
Applicant Holder Full Name: MACLEODS PHARMACEUTICALS LTD
Marketing Status: Prescription
Patent and Exclusivity Information