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Details for New Drug Application (NDA): 074805

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NDA 074805 describes FLUNISOLIDE, which is a drug marketed by Hi Tech Pharma Co, Bausch And Lomb, and Apotex Inc, and is included in three NDAs. It is available from four 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. Six suppliers are listed for this compound. Additional details are available on the flunisolide profile page.

Summary for NDA: 074805

Tradename:
FLUNISOLIDE
Applicant:
Bausch And Lomb
Ingredient:
flunisolide
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

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
FLUNISOLIDE
flunisolide
SPRAY, METERED;NASAL 074805 ANDA Physicians Total Care, Inc. 54868-4799 54868-4799-0 1 BOTTLE, PUMP in 1 CARTON (54868-4799-0) > 25 mL in 1 BOTTLE, PUMP

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.025MG/SPRAY
Approval Date:Feb 20, 2002TE:ABRLD:Yes


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