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Details for Generic Name: flunisolide

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Flunisolide is the generic ingredient in five branded drugs marketed by Roche Palo, Meda Pharms Inc, Apotex Inc, Bausch And Lomb, Hi Tech Pharma Co, Ivax Res, and Teva Branded Pharm, and is included in seven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for flunisolide. One supplier is listed for this compound.

Summary for Generic Name: flunisolide

Drug Master File Entries: see list12
Suppliers: see list1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: flunisolide

Clinical Trials for: flunisolide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch And Lomb
SPRAY, METERED;NASAL074805-001Feb 20, 2002RXYes<disabled><disabled>
Meda Pharms Inc
AEROSOL, METERED;INHALATION021247-001Jan 27, 2006RXYes5,776,433<disabled>Y<disabled>
Roche Palo
AEROSOL, METERED;INHALATION018340-001Aug 17, 1984DISCNNo<disabled><disabled>
Ivax Res
SPRAY, METERED;NASAL018148-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
Hi Tech Pharma Co
SPRAY, METERED;NASAL077704-001Aug 3, 2006RXNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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