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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202547

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ARIPIPRAZOLE (ARIPIPRAZOLE)
10MG
Marketing Status: Prescription
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ARIPIPRAZOLE
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202547
Product Number: 001
Approval Date: Dec 11, 2017
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE 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, ORALLY DISINTEGRATING; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202547
Product Number: 002
Approval Date: Dec 11, 2017
Applicant Holder Full Name: ORBION PHARMACEUTICALS PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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