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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 20, 2018

DrugPatentWatch Database Preview

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 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. Five suppliers are listed for this compound. Additional details are available on the flunisolide profile page.

Summary for 077704

Tradename:	FLUNISOLIDE
Applicant:	Hi Tech Pharma Co
Ingredient:	flunisolide
Patents:	0
Therapeutic Class:	Respiratory Tract Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077704

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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	E	64980-510-25

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY, METERED;NASAL			Strength	0.025MG/SPRAY
Approval Date:	Aug 3, 2006	TE:	AB	RLD:	No

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