`
`Ex [ZZA] FDA Orange Book - Flunisolide
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Approval Date
`Mkt.Status Active Ingredient Proprietary Name Appl No Product Number Dosage Form
`Route
`Strength
`TE Code RLD
`RS Applicant Holder
`Approved Prior to Jan 1, 1982
`DISCN
`FLUNISOLIDE
`NASALIDE
`N018148 001
`SPRAY, METERED
`NASAL
`0.025MG/SPRAY
`IVAX RESEARCH INC
`Feb 20, 2002
`RX
`FLUNISOLIDE
`FLUNISOLIDE
`A074805 001
`SPRAY, METERED
`NASAL
`0.025MG/SPRAY AB
`RS BAUSCH AND LOMB PHARMACEUTICALS INC
`Aug 3, 2006
`RX
`FLUNISOLIDE
`FLUNISOLIDE
`A077704 001
`SPRAY, METERED
`NASAL
`0.025MG/SPRAY AB
`HI TECH PHARMACAL CO INC
`DISCN
`FLUNISOLIDE
`NASAREL
`N020409 001
`SPRAY, METERED
`NASAL
`0.029MG/SPRAY
`TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC Mar 8, 1995
`RX
`FLUNISOLIDE
`FLUNISOLIDE
`A077436 001
`SPRAY, METERED
`NASAL
`0.029MG/SPRAY
`RS APOTEX INC RICHMOND HILL
`Aug 9, 2007
`DISCN
`FLUNISOLIDE
`AEROBID
`N018340 001
`AEROSOL, METERED INHALATION 0.25MG/INH
`ROCHE PALO ALTO LLC
`Aug 17, 1984
`RX
`FLUNISOLIDE
`AEROSPAN HFA
`N021247 001
`AEROSOL, METERED INHALATION 0.078MG/INH
`RS MYLAN SPECIALTY LP
`Jan 27, 2006
`
`RLD
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1108
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`
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