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FDA Orange Book - Beclomethasone
`
`2/26/2018
`
`Mkt.Status Active Ingredient
`DISCN
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE MONOHYDRATE
`BECLOMETHASONE DIPROPIONATE
`DISCN
`DISCN
`BECLOMETHASONE DIPROPIONATE MONOHYDRATE
`DISCN
`BECLOMETHASONE DIPROPIONATE MONOHYDRATE
`RX
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE
`RX
`BECLOMETHASONE DIPROPIONATE
`DISCN
`BECLOMETHASONE DIPROPIONATE
`DISCN
`BECLOMETHASONE DIPROPIONATE
`DISCN
`BECLOMETHASONE DIPROPIONATE
`
`Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
`Appl No
`Product Number Dosage Form
`Route
`Strength
`Proprietary Name
`N018584 001
`AEROSOL, METERED NASAL
`0.042MG/INH
`BECONASE
`N019389 001
`SPRAY, METERED
`NASAL
`EQ 0.042MG DIPROP/SPRAY
`BECONASE AQ
`N018521 001
`AEROSOL, METERED NASAL
`0.042MG/INH
`VANCENASE
`N019589 001
`SPRAY, METERED
`NASAL
`EQ 0.042MG DIPROP/SPRAY
`VANCENASE AQ
`N020469 001
`SPRAY, METERED
`NASAL
`EQ 0.084MG DIPROP/SPRAY
`VANCENASE AQ
`N202813 002
`AEROSOL, METERED NASAL
`0.04MG/ACTUATION
`QNASL
`N202813 001
`AEROSOL, METERED NASAL
`0.08MG/ACTUATION
`QNASL
`N020911 002
`AEROSOL, METERED INHALATION
`0.04MG/INH
`QVAR 40
`N020911 001
`AEROSOL, METERED INHALATION
`0.08MG/INH
`QVAR 80
`N207921 001
`AEROSOL, METERED INHALATION
`0.04MG/INH
`QVAR REDIHALER
`N207921 002
`AEROSOL, METERED INHALATION
`0.08MG/INH
`QVAR REDIHALER
`N018153 001
`AEROSOL, METERED INHALATION
`0.042MG/INH
`BECLOVENT
`N017573 001
`AEROSOL, METERED INHALATION
`0.042MG/INH
`VANCERIL
`VANCERIL DOUBLE STRENGTH N020486 001
`AEROSOL, METERED INHALATION
`0.084MG/INH
`
`Approval Date
`TE Code RLD RS Applicant Holder
`Approved Prior to Jan 1, 1982
`GLAXOSMITHKLINE
`Jul 27, 1987
`RLD RS GLAXOSMITHKLINE
`SCHERING CORP SUB SCHERING PLApproved Prior to Jan 1, 1982
`SCHERING CORP SUB SCHERING PLDec 23, 1987
`SCHERING CORP
`Jun 26, 1996
`TEVA BRANDED PHARMACEUTICA Dec 17, 2014
`RLD
`RLD RS TEVA BRANDED PHARMACEUTICA Mar 23, 2012
`RLD RS TEVA BRANDED PHARMACEUTICA Sep 15, 2000
`RLD RS TEVA BRANDED PHARMACEUTICA Sep 15, 2000
`RLD
`NORTON WATERFORD LTD
`Aug 3, 2017
`RLD RS NORTON WATERFORD LTD
`Aug 3, 2017
`GLAXOSMITHKLINE
`Approved Prior to Jan 1, 1982
`SCHERING CORP SUB SCHERING PLApproved Prior to Jan 1, 1982
`SCHERING CORP
`Dec 24, 1996
`
`https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
`
`Exhibit 1070
`IPR2017-00807
`ARGENTUM
`
`Page 1 of 1
`
`000001
`
`

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