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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016851

Marketing Status: Prescription
Active Ingredient: FLUOROMETHOLONE
Proprietary Name: FML
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N016851
Product Number: 002
Approval Date: Jul 28, 1982
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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