IPR2017-00807, No. 1115 Exhibit - Budesonide (P.T.A.B. Mar. 6, 2018)

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IPR2017-00807, No. 1115 Exhibit - Budesonide (P.T.A.B. Mar. 6, 2018)

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FDA Orange Book - Budesonide
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`BUDESONIDE
`DISCN
`OTC
`BUDESONIDE
`OTC
`BUDESONIDE
`RX
`BUDESONIDE
`BUDESONIDE
`RX
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE
`RX
`BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
`RX
`BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
`DISCN
`BUDESONIDE
`DISCN
`BUDESONIDE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Route
`Strength
`Proprietary Name
`N020233 001
`AEROSOL, METERED
`NASAL
`0.032MG/INH
`RHINOCORT
`N020746 003
`SPRAY, METERED
`NASAL
`0.032MG/SPRAY
`RHINOCORT ALLERGY
`A078949 002
`SPRAY, METERED
`NASAL
`0.032MG/SPRAY
`BUDESONIDE
`N205613 001
`AEROSOL, FOAM
`RECTAL
`2MG/ACTUATION
`UCERIS
`A206724 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A206200 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A207367 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A090379 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A206623 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A090410 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A209041 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`A206134 001
`CAPSULE
`ORAL
`3MG
`BUDESONIDE
`N021324 001
`CAPSULE
`ORAL
`3MG
`ENTOCORT EC
`PULMICORT FLEXHALER N021949 001
`POWDER, METERED
`INHALATION 0.08MG/INH
`PULMICORT FLEXHALER N021949 002
`POWDER, METERED
`INHALATION 0.16MG/INH
`BUDESONIDE
`A078202 001
`SUSPENSION
`INHALATION 0.25MG/2ML
`BUDESONIDE
`A205710 001
`SUSPENSION
`INHALATION 0.25MG/2ML
`BUDESONIDE
`A078404 001
`SUSPENSION
`INHALATION 0.25MG/2ML
`BUDESONIDE
`A201966 003
`SUSPENSION
`INHALATION 0.25MG/2ML
`BUDESONIDE
`A077519 001
`SUSPENSION
`INHALATION 0.25MG/2ML
`BUDESONIDE
`A078202 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`BUDESONIDE
`A205710 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`BUDESONIDE
`A078404 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`BUDESONIDE
`A201966 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`BUDESONIDE
`A077519 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`BUDESONIDE
`A205710 003
`SUSPENSION
`INHALATION 1MG/2ML
`BUDESONIDE
`A201966 001
`SUSPENSION
`INHALATION 1MG/2ML
`BUDESONIDE
`A204548 001
`SUSPENSION
`INHALATION 1MG/2ML
`PULMICORT RESPULES
`N020929 001
`SUSPENSION
`INHALATION 0.25MG/2ML
`PULMICORT RESPULES
`N020929 002
`SUSPENSION
`INHALATION 0.5MG/2ML
`PULMICORT RESPULES
`N020929 003
`SUSPENSION
`INHALATION 1MG/2ML
`UCERIS
`N203634 001
`TABLET, EXTENDED RELEASE ORAL
`9MG
`SYMBICORT
`N021929 001
`AEROSOL, METERED
`INHALATION 0.08MG/INH; 0.0045MG/INH
`SYMBICORT
`N021929 002
`AEROSOL, METERED
`INHALATION 0.16MG/INH; 0.0045MG/INH
`PULMICORT
`N020441 002
`POWDER, METERED
`INHALATION 0.16MG/INH
`PULMICORT
`N020441 003
`POWDER, METERED
`INHALATION 0.32MG/INH
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`AB
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Feb 14, 1994
`ASTRAZENECA LP
`RLD RS ASTRAZENECA PHARMACEUTICALS L Mar 23, 2015
`APOTEX INC RICHMOND HILL
`Nov 20, 2015
`RLD RS VALEANT PHARMACEUTICALS INTER Oct 7, 2014
`ALVOGEN MALTA OPERATIONS LTD Nov 23, 2016
`AMNEAL PHARMACEUTICALS OF NE
`Jul 31, 2017
`APPCO PHARMA LLC
`Apr 7, 2017
`BARR LABORATORIES INC SUB TEVA Apr 2, 2014
`MAYNE PHARMA LLC
`Apr 8, 2016
`MYLAN PHARMACEUTICALS INC
`May 16, 2011
`SCIECURE PHARMA INC
`Sep 28, 2017
`ZYDUS PHARMACEUTICALS USA INC May 4, 2017
`RLD RS PERRIGO PHARMA INTERNATIONAL Oct 2, 2001
`RLD
`ASTRAZENECA LP
`Jul 12, 2006
`RLD RS ASTRAZENECA LP
`Jul 12, 2006
`APOTEX INC
`Mar 30, 2009
`CIPLA LTD
`Nov 16, 2017
`IMPAX LABORATORIES INC
`Jul 31, 2012
`SANDOZ INC
`Sep 27, 2013
`TEVA PHARMACEUTICALS USA
`Nov 18, 2008
`APOTEX INC
`Mar 30, 2009
`CIPLA LTD
`Nov 16, 2017
`IMPAX LABORATORIES INC
`Jul 31, 2012
`SANDOZ INC
`Sep 27, 2013
`TEVA PHARMACEUTICALS USA
`Nov 18, 2008
`CIPLA LTD
`Nov 16, 2017
`SANDOZ INC
`Sep 27, 2013
`TEVA PHARMACEUTICALS USA
`Mar 8, 2016
`ASTRAZENECA PHARMACEUTICALS L Aug 8, 2000
`RLD
`ASTRAZENECA PHARMACEUTICALS L Aug 8, 2000
`RLD
`RLD RS ASTRAZENECA PHARMACEUTICALS L Aug 8, 2000
`RLD RS VALEANT PHARMACEUTICALS INTER Jan 14, 2013
`RLD RS ASTRAZENECA LP
`Jul 21, 2006
`RLD RS ASTRAZENECA LP
`Jul 21, 2006
`ASTRAZENECA PHARMACEUTICALS L Jun 24, 1997
`ASTRAZENECA PHARMACEUTICALS L Jun 24, 1997
`
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`AN
`
`Exhibit 1115
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`

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