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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206220

BEPOTASTINE BESILATE (BEPOTASTINE BESILATE)
1.5%
Marketing Status: Prescription
Active Ingredient: BEPOTASTINE BESILATE
Proprietary Name: BEPOTASTINE BESILATE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 1.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A206220
Product Number: 001
Approval Date: Mar 18, 2019
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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