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Last Updated: November 12, 2024

Details for New Drug Application (NDA): 216348


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NDA 216348 describes FLUOROMETHOLONE, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the FLUOROMETHOLONE profile page.

The generic ingredient in FLUOROMETHOLONE is fluorometholone. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluorometholone profile page.
Summary for 216348
Tradename:FLUOROMETHOLONE
Applicant:Amneal
Ingredient:fluorometholone
Patents:0
Pharmacology for NDA: 216348
Medical Subject Heading (MeSH) Categories for 216348
Suppliers and Packaging for NDA: 216348
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOROMETHOLONE fluorometholone SUSPENSION/DROPS;OPHTHALMIC 216348 ANDA Amneal Pharmaceuticals NY LLC 60219-1585 60219-1585-3 1 BOTTLE, DROPPER in 1 CARTON (60219-1585-3) / 5 mL in 1 BOTTLE, DROPPER
FLUOROMETHOLONE fluorometholone SUSPENSION/DROPS;OPHTHALMIC 216348 ANDA Amneal Pharmaceuticals NY LLC 60219-1586 60219-1586-6 1 BOTTLE, DROPPER in 1 CARTON (60219-1586-6) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Jan 9, 2024TE:ABRLD:No
Regulatory Exclusivity Expiration:Jul 7, 2024
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

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