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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019216

FML FORTE (FLUOROMETHOLONE)
0.25%
Marketing Status: Prescription
Active Ingredient: FLUOROMETHOLONE
Proprietary Name: FML FORTE
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.25%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019216
Product Number: 001
Approval Date: Apr 23, 1986
Applicant Holder Full Name: ABBVIE INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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