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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077838

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE (BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE)
3MG/ML;EQ 3MG BASE/ML
Marketing Status: Prescription
Active Ingredient: BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
Proprietary Name: BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 3MG/ML;EQ 3MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077838
Product Number: 001
Approval Date: Jan 17, 2023
Applicant Holder Full Name: HIKMA FARMACEUTICA PORTUGAL SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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