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Product Details for ANDA 216348

FLUOROMETHOLONE (FLUOROMETHOLONE)
0.1%
Marketing Status: Prescription
Active Ingredient: FLUOROMETHOLONE
Proprietary Name: FLUOROMETHOLONE
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.1%
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216348
Product Number: 001
Approval Date: Jan 9, 2024
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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