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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 206027

BROMFENAC SODIUM (BROMFENAC SODIUM)
EQ 0.07% ACID
Marketing Status: Prescription
Active Ingredient: BROMFENAC SODIUM
Proprietary Name: BROMFENAC SODIUM
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: EQ 0.07% ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206027
Product Number: 001
Approval Date: Nov 22, 2023
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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