Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 203025

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ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 001
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 002
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 003
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 004
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 005
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

ARIPIPRAZOLE (ARIPIPRAZOLE)
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: A203025
Product Number: 006
Approval Date: Dec 1, 2021
Applicant Holder Full Name: UNICHEM LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information