IPR2017-00807, No. 1116-275 Exhibit - Mometasone (P.T.A.B. Mar. 6, 2018)

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IPR2017-00807, No. 1116-275 Exhibit - Mometasone (P.T.A.B. Mar. 6, 2018)

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FDA Orange Book - Mometasone
`
`2/26/2018
`
`Proprietary Name
`Mkt.Status Active Ingredient
`NASONEX
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`SINUVA
`RX
`MOMETASONE FUROATE
`ASMANEX TWISTHALER
`RX
`MOMETASONE FUROATE
`ASMANEX TWISTHALER
`RX
`MOMETASONE FUROATE
`RX
`FORMOTEROL FUMARATE; MOMETASONE FUROATE DULERA
`RX
`FORMOTEROL FUMARATE; MOMETASONE FUROATE DULERA
`RX
`MOMETASONE FUROATE
`ASMANEX HFA
`RX
`MOMETASONE FUROATE
`ASMANEX HFA
`RX
`MOMETASONE FUROATE
`ELOCON
`DISCN
`MOMETASONE FUROATE
`ELOCON
`RX
`MOMETASONE FUROATE
`ELOCON
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`DISCN
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`MOMETASONE FUROATE
`RX
`MOMETASONE FUROATE
`ELOCON
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Route
`Strength
`N020762 001
`SPRAY, METERED
`NASAL
`EQ 0.05MG BASE/SPRAY
`A091161 001
`SPRAY, METERED
`NASAL
`EQ 0.05MG BASE/SPRAY
`A207989 001
`SPRAY, METERED
`NASAL
`EQ 0.05MG BASE/SPRAY
`N209310 001
`IMPLANT
`IMPLANTATION 1.35MG
`N021067 001
`POWDER
`INHALATION
`0.22MG/INH
`N021067 002
`POWDER
`INHALATION
`0.11MG/INH
`N022518 001
`AEROSOL, METERED INHALATION
`0.005MG/INH; 0.1MG/INH
`N022518 002
`AEROSOL, METERED INHALATION
`0.005MG/INH; 0.2MG/INH
`N205641 001
`AEROSOL, METERED INHALATION
`0.10MG/INH
`N205641 002
`AEROSOL, METERED INHALATION
`0.20MG/INH
`N019543 001
`OINTMENT
`TOPICAL
`N019625 001
`CREAM
`TOPICAL
`N019796 001
`LOTION
`TOPICAL
`A076067 001
`OINTMENT
`TOPICAL
`A076481 001
`OINTMENT
`TOPICAL
`A076624 001
`OINTMENT
`TOPICAL
`A076679 001
`CREAM
`TOPICAL
`A077061 001
`OINTMENT
`TOPICAL
`A077180 001
`LOTION
`TOPICAL
`A076171 001
`CREAM
`TOPICAL
`A076788 001
`LOTION
`TOPICAL
`A077447 001
`CREAM
`TOPICAL
`A077401 001
`OINTMENT
`TOPICAL
`A076591 001
`CREAM
`TOPICAL
`A077678 001
`LOTION
`TOPICAL
`A076499 001
`LOTION
`TOPICAL
`A075919 001
`LOTION
`TOPICAL
`A078541 001
`CREAM
`TOPICAL
`A078571 001
`OINTMENT
`TOPICAL
`A090506 001
`LOTION
`TOPICAL
`N019625 002
`CREAM
`TOPICAL
`
`Approval Date
`TE Code RLD RS Applicant Holder
`AB
`RLD RS MERCK SHARP AND DOHME CORP Oct 1, 1997
`AB
`APOTEX INC
`Mar 22, 2016
`AB
`AMNEAL PHARMACEUTICALS
`Apr 3, 2017
`INTERSECT ENT INC
`Dec 8, 2017
`RLD
`RLD RS MERCK SHARP AND DOHME CORP Mar 30, 2005
`RLD
`MERCK SHARP AND DOHME CORP Feb 1, 2008
`RLD RS MERCK SHARP AND DOHME CORP Jun 22, 2010
`RLD RS MERCK SHARP AND DOHME CORP Jun 22, 2010
`RLD
`MERCK SHARP AND DOHME CORP Apr 25, 2014
`RLD RS MERCK SHARP AND DOHME CORP Apr 25, 2014
`RLD RS MERCK SHARP AND DOHME CORP Apr 30, 1987
`MERCK SHARP AND DOHME CORP May 6, 1987
`RLD RS MERCK SHARP AND DOHME CORP Mar 30, 1989
`PERRIGO NEW YORK INC
`Mar 18, 2002
`TOLMAR INC
`Nov 14, 2003
`TARO PHARMACEUTICALS USA INC Dec 3, 2004
`TARO PHARMACEUTICALS USA INC Dec 21, 2004
`FOUGERA PHARMACEUTICALS INC Mar 28, 2005
`PERRIGO ISRAEL PHARMACEUTICALSApr 6, 2005
`FOUGERA PHARMACEUTICALS INC Apr 8, 2005
`TARO PHARMACEUTICALS USA INC Mar 15, 2006
`G AND W LABORATORIES INC
`May 22, 2006
`G AND W LABORATORIES INC
`Jun 20, 2006
`TOLMAR INC
`Apr 18, 2007
`G AND W LABORATORIES INC
`Nov 21, 2007
`TOLMAR INC
`Nov 21, 2007
`FOUGERA PHARMACEUTICALS INC Nov 29, 2007
`GLENMARK GENERICS INC USA
`May 28, 2008
`GLENMARK GENERICS INC USA
`May 28, 2008
`GLENMARK GENERICS LTD
`Aug 9, 2010
`RLD RS MERCK SHARP AND DOHME CORP Apr 19, 2013
`
`0.1% AB
`0.1%
`0.1% AB
`0.1% AB
`0.1% AB
`0.1%
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`0.1% AB
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1116
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`

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