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Last Updated: December 16, 2019

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Details for New Drug Application (NDA): 077704

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NDA 077704 describes FLUNISOLIDE, which is a drug marketed by Apotex Inc, Bausch And Lomb, and Hi Tech Pharma Co, and is included in three NDAs. It is available from three 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. Three suppliers are listed for this compound. Additional details are available on the flunisolide profile page.
Summary for 077704
Applicant:Hi Tech Pharma Co
Formulation / Manufacturing:see details
Pharmacology for NDA: 077704
Suppliers and Packaging for NDA: 077704
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUNISOLIDE flunisolide SPRAY, METERED;NASAL 077704 ANDA Rising Pharmaceuticals, Inc 64980-510 64980-510-25 1 BOTTLE, SPRAY in 1 CARTON (64980-510-25) > 25 mL in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.025MG/SPRAY
Approval Date:Aug 3, 2006TE:ABRLD:No

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