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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074805


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NDA 074805 describes FLUNISOLIDE, which is a drug marketed by Apotex, Bausch, Riconpharma Llc, and Rising, and is included in four NDAs. It is available from two suppliers. Additional details are available on the FLUNISOLIDE profile page.

The generic ingredient in FLUNISOLIDE is flunisolide. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the flunisolide profile page.
Summary for 074805
Tradename:FLUNISOLIDE
Applicant:Bausch
Ingredient:flunisolide
Patents:0
Pharmacology for NDA: 074805
Suppliers and Packaging for NDA: 074805
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUNISOLIDE flunisolide SPRAY, METERED;NASAL 074805 ANDA Bausch & Lomb Incorporated 24208-344 24208-344-25 1 BOTTLE, PUMP in 1 CARTON (24208-344-25) / 25 mL in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.025MG/SPRAY
Approval Date:Feb 20, 2002TE:ABRLD:No

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