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FDA Orange Book - Fluticasone Propionate
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`RX
`AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
`RX
`AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`OTC
`FLUTICASONE PROPIONATE
`OTC
`FLUTICASONE PROPIONATE
`OTC
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`DISCN
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`RX
`FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Approval Date
`TE Code RLD RS Applicant Holder
`Appl No
`Product Number Dosage Form
`Route
`Strength
`Proprietary Name
`May 1, 2012
`AB
`RLD RS MYLAN SPECIALTY LP
`N202236 001
`SPRAY, METERED
`NASAL
`EQ 0.125MG BASE/SPRAY; 0.05MG/SPRAY
`DYMISTA
`Apr 28, 2017
`AB
`APOTEX INC
`AZELASTINE HYDROCHLORIDE AND FLUTICASOA207712 001
`SPRAY, METERED
`NASAL
`EQ 0.125MG BASE/SPRAY; 0.05MG/SPRAY
`Oct 19, 1994
`FLONASE
`N020121 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY **Federal Register determination that pr RLD
`GLAXOSMITHKLINE
`FLUTICASONE PROPIONATE
`A076504 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`AB
`RS WEST-WARD PHARMACEUTICALS INTERNAFeb 22, 2006
`FLUTICASONE PROPIONATE
`A077538 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`AB
`APOTEX INC RICHMOND HILL
`Sep 12, 2007
`FLUTICASONE PROPIONATE
`A077570 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`AB
`HI TECH PHARMACAL CO INC
`Jan 16, 2008
`FLUTICASONE PROPIONATE
`A078492 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`AB
`WOCKHARDT EU OPERATIONS (SWISS) AGJan 9, 2012
`FLONASE ALLERGY RELIEF
`N205434 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`RLD RS GLAXOSMITHKLINE CONSUMER HEALTHC Jul 23, 2014
`FLUTICASONE PROPIONATE
`A208150 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`APOTEX INC
`Feb 29, 2016
`FLUTICASONE PROPIONATE
`A207957 001
`SPRAY, METERED
`NASAL
`0.05MG/SPRAY
`WEST-WARD PHARMACEUTICALS INTERNAMay 26, 2016
`XHANCE
`N209022 001
`SPRAY, METERED
`NASAL
`0.093MG
`RLD RS OPTNOSE US INC
`Sep 18, 2017
`FLOVENT
`N020549 001
`POWDER
`INHALATION 0.044MG/INH
`GLAXOSMITHKLINE
`Nov 7, 1997
`FLOVENT
`N020549 002
`POWDER
`INHALATION 0.088MG/INH
`GLAXOSMITHKLINE
`Nov 7, 1997
`FLOVENT
`N020549 003
`POWDER
`INHALATION 0.22MG/INH
`GLAXOSMITHKLINE
`Nov 7, 1997
`FLOVENT DISKUS 100
`N020833 002
`POWDER
`INHALATION 0.1MG/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOSep 29, 2000
`FLOVENT DISKUS 250
`N020833 003
`POWDER
`INHALATION 0.25MG/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOSep 29, 2000
`FLOVENT DISKUS 50
`N020833 001
`POWDER
`INHALATION 0.05MG/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOSep 29, 2000
`ARMONAIR RESPICLICK
`N208798 001
`POWDER
`INHALATION 0.055MG/INH
`RLD
`TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`ARMONAIR RESPICLICK
`N208798 002
`POWDER
`INHALATION 0.113MG/INH
`RLD
`TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`ARMONAIR RESPICLICK
`N208798 003
`POWDER
`INHALATION 0.232MG/INH
`RLD RS TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`ADVAIR DISKUS 100/50
`N021077 001
`POWDER
`INHALATION 0.1MG/INH; EQ 0.05MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOAug 24, 2000
`ADVAIR DISKUS 250/50
`N021077 002
`POWDER
`INHALATION 0.25MG/INH; EQ 0.05MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOAug 24, 2000
`ADVAIR DISKUS 500/50
`N021077 003
`POWDER
`INHALATION 0.5MG/INH; EQ 0.05MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOAug 24, 2000
`AIRDUO RESPICLICK
`N208799 001
`POWDER
`INHALATION 0.055MG/INH; EQ 0.014MG BASE/INH
`RLD
`TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`AIRDUO RESPICLICK
`N208799 002
`POWDER
`INHALATION 0.113MG/INH; EQ 0.014MG BASE/INH
`RLD
`TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`AIRDUO RESPICLICK
`N208799 003
`POWDER
`INHALATION 0.232MG/INH; EQ 0.014MG BASE/INH
`RLD RS TEVA PHARMACEUTICAL INDUSTRIES LTD Jan 27, 2017
`CUTIVATE
`N019957 001
`OINTMENT
`TOPICAL
`RLD RS FOUGERA PHARMACEUTICALS INC
`Dec 14, 1990
`FLUTICASONE PROPIONATE
`A076300 001
`OINTMENT
`TOPICAL
`FOUGERA PHARMACEUTICALS INC
`May 14, 2004
`FLUTICASONE PROPIONATE
`A076668 001
`OINTMENT
`TOPICAL
`PERRIGO NEW YORK INC
`May 14, 2004
`FLUTICASONE PROPIONATE
`A077145 001
`OINTMENT
`TOPICAL
`TARO PHARMACEUTICAL INDUSTRIES LTD Jun 14, 2005
`FLUTICASONE PROPIONATE
`A077168 001
`OINTMENT
`TOPICAL
`G AND W LABORATORIES INC
`Mar 3, 2006
`CUTIVATE
`N021152 001
`LOTION
`TOPICAL
`RLD RS FOUGERA PHARMACEUTICALS INC
`Mar 31, 2005
`FLUTICASONE PROPIONATE
`A090759 001
`LOTION
`TOPICAL
`GLENMARK GENERICS LIMITED
`May 2, 2011
`FLUTICASONE PROPIONATE
`A091553 001
`LOTION
`TOPICAL
`PERRIGO ISRAEL PHARMACEUTICALS LTD Jul 30, 2013
`CUTIVATE
`N019958 001
`CREAM
`TOPICAL
`FOUGERA PHARMACEUTICALS INC
`Dec 18, 1990
`FLUTICASONE PROPIONATE
`A076451 001
`CREAM
`TOPICAL
`FOUGERA PHARMACEUTICALS INC
`May 14, 2004
`FLUTICASONE PROPIONATE
`A076793 001
`CREAM
`TOPICAL
`RS PERRIGO NEW YORK INC
`May 14, 2004
`FLUTICASONE PROPIONATE
`A076633 001
`CREAM
`TOPICAL
`TOLMAR INC
`May 14, 2004
`FLUTICASONE PROPIONATE
`A076865 001
`CREAM
`TOPICAL
`NESHER PHARMACEUTICALS USA LLC
`Sep 10, 2004
`FLUTICASONE PROPIONATE
`A077055 001
`CREAM
`TOPICAL
`G AND W LABORATORIES INC
`Jun 30, 2006
`FLOVENT
`N020548 001
`AEROSOL, METERED INHALATION 0.044MG/INH
`GLAXOSMITHKLINE
`Mar 27, 1996
`FLOVENT
`N020548 002
`AEROSOL, METERED INHALATION 0.11MG/INH
`GLAXOSMITHKLINE
`Mar 27, 1996
`FLOVENT
`N020548 003
`AEROSOL, METERED INHALATION 0.22MG/INH
`GLAXOSMITHKLINE
`Mar 27, 1996
`FLOVENT HFA
`N021433 003
`AEROSOL, METERED INHALATION 0.044MG/INH
`RLD RS GLAXO GROUP LTD DBA GLAXOSMITHKLI May 14, 2004
`FLOVENT HFA
`N021433 002
`AEROSOL, METERED INHALATION 0.11MG/INH
`RLD RS GLAXO GROUP LTD DBA GLAXOSMITHKLI May 14, 2004
`FLOVENT HFA
`N021433 001
`AEROSOL, METERED INHALATION 0.22MG/INH
`RLD RS GLAXO GROUP LTD DBA GLAXOSMITHKLI May 14, 2004
`ADVAIR HFA
`N021254 001
`AEROSOL, METERED INHALATION 0.045MG/INH; EQ 0.021MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOJun 8, 2006
`ADVAIR HFA
`N021254 002
`AEROSOL, METERED INHALATION 0.115MG/INH; EQ 0.021MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOJun 8, 2006
`ADVAIR HFA
`N021254 003
`AEROSOL, METERED INHALATION 0.23MG/INH; EQ 0.021MG BASE/INH
`RLD RS GLAXO GROUP LTD ENGLAND DBA GLAXOJun 8, 2006
`
`0% AB
`0% AB
`0% AB
`0%
`0% AB
`0% AB
`0% AB
`0% AB
`0.05% **Federal Register determination that product wa RLD
`0% AB
`0% AB
`0% AB
`0%
`0% AB
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1113
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`

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