`
`Page 1 of 3
`
`FDA Home3 Drug Databases4 Inactive Ingredient Search
`Inactive Ingredient Search for Approved Drug Products
`About this Database5 Back to Search Page
`
`Search Results for: "butylated"
`
`CAS NUMBER8
`24938167
`
`UNII9
`905HNO1SIH
`
`MAXIMUM POTENCY10
`10MG
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`0.03%
`
`0.0003%
`
`2%
`
`0.0002%
`
`0.1MG
`
`1MG
`
`0.0075%
`
`0.0189%
`
`0.05%
`
`0.5MG
`
`ROUTE;DOSAGE FORM7
`ORAL; TABLET, ORALLY
`DISINTEGRATING
`
`INTRAMUSCULAR;
`INJECTION
`IV(INFUSION); INJECTION
`
`IV(INFUSION); POWDER,
`FOR INJECTION SOLUTION
`NASAL; SOLUTION
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`NASAL; SPRAY, METERED
`
`25013165
`
`ORAL; CAPSULE
`
`ORAL; CAPSULE, SOFT
`GELATIN
`ORAL; CONCENTRATE
`
`ORAL; EMULSION
`
`ORAL; GRANULE, FOR
`SUSPENSION
`ORAL; SOLUTION
`
`ORAL; SUSPENSION
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`INACTIVEINGREDIENT6
`BASIC BUTYLATED
`METHACRYLATE
`COPOLYMER
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`HYDROXYANISOLE
`BUTYLATED
`
`ORAL; TABLET
`
`ORAL; TABLET, FILM
`COATED
`ORAL; TABLET, ORALLY
`DISINTEGRATING
`RECTAL; SUPPOSITORY
`
`SUBLINGUAL; TABLET
`
`TOPICAL; EMULSION,
`CREAM
`TOPICAL; GEL
`
`TOPICAL; LOTION
`
`TOPICAL; OINTMENT
`
`TOPICAL; SOLUTION
`
`VAGINAL; EMULSION,
`CREAM
`VAGINAL; OINTMENT
`
`VAGINAL; SUPPOSITORY
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`25013165
`
`BUCCAL; GUM, CHEWING
`
`128370
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`REK4960K2U
`
`1P9D0Z171K
`
`0.4MG
`
`0.16MG
`
`0.213MG
`
`0.5MG
`
`0.1%
`
`0.05%
`
`0.005%
`
`0.125%
`
`0.02%
`
`1MG
`
`0.21MG
`
`http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm
`
`12/30/2014
`
`NOVARTIS EXHIBIT 2047
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 1 of 4
`
`
`
`Inactive Ingredient Search for Approved Drug Products
`
`Page 2 of 3
`
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`
`INTRAMUSCULAR;
`INJECTION
`INTRAVENOUS; POWDER,
`FOR INJECTION SOLUTION,
`LYOPHILIZED
`INTRAVENOUS; SOLUTION,
`INJECTION
`IV(INFUSION); INJECTION
`
`IV(INFUSION); POWDER,
`FOR INJECTION SOLUTION
`NASAL; SPRAY, METERED
`
`ORAL; CAPSULE
`
`ORAL; CAPSULE, SOFT
`GELATIN
`ORAL; FILM, SOLUBLE
`
`ORAL; SOLUTION
`
`ORAL; SOLUTION, LIQUID,
`CONCENTRATE, ORAL
`ORAL; TABLET
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`0.03%
`
`0.0015%
`
`0.002%
`
`0.001%
`
`0.01%
`
`0.2MG
`
`0.25MG
`
`0.06MG
`
`0.0189%
`
`0.01%
`
`0.4MG
`
`0.15MG
`
`0.21MG
`
`0.11MG
`
`0.36MG
`
`ORAL; TABLET
`(IMMED./COMP. RELEASE),
`FILM COATED
`ORAL; TABLET,
`CONTROLLED RELEASE
`ORAL; TABLET, EXTENDED
`RELEASE
`ORAL; TABLET, FILM
`COATED
`ORAL; TABLET, FOR
`SUSPENSION
`ORAL; TABLET, SUSTAINED
`ACTION
`RECTAL; SUPPOSITORY
`
`TOPICAL; AEROSOL
`
`TOPICAL; CREAM,
`AUGMENTED
`TOPICAL; CREAM,
`EMULSION, SUSTAINED
`RELEASE
`TOPICAL; EMULSION,
`AEROSOL FOAM
`TOPICAL; EMULSION,
`CREAM
`TOPICAL; GEL
`
`TOPICAL; LOTION
`
`TOPICAL; OINTMENT
`
`TOPICAL; SHAMPOO
`
`TOPICAL; SOLUTION
`
`TOPICAL; SWAB
`
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`128370
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`0.1MG
`
`0.24MG
`
`0.213MG
`
`0.1%
`
`0.05%
`
`0.1%
`
`0.1%
`
`0.1%
`
`2%
`
`0.02%
`
`0.025%
`
`0.1%
`
`0.088%
`
`http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm
`
`12/30/2014
`
`NOVARTIS EXHIBIT 2047
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 2 of 4
`
`
`
`Inactive Ingredient Search for Approved Drug Products
`
`Page 3 of 3
`
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`BUTYLATED
`HYDROXYTOLUENE
`
`TRANSDERMAL; GEL
`
`VAGINAL; EMULSION,
`CREAM
`VAGINAL; SUPPOSITORY
`
`128370
`
`128370
`
`128370
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`1P9D0Z171K
`
`0.05%
`
`0.05%
`
`Update Frequency: Quarterly
`Data Through: September 16, 2013
`Database Last Updated: October 24, 2013
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.fda.gov/Drugs/InformationOnDrugs/ucm080123.htm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`9. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News &
`Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm
`
`12/30/2014
`
`NOVARTIS EXHIBIT 2047
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 3 of 4
`
`
`
`Inactive Ingredient Search for Approved Drug Products
`
`Page 1 of 1
`
`FDA Home3 Drug Databases4 Inactive Ingredient Search
`Inactive Ingredient Search for Approved Drug Products
`About this Database5 Back to Search Page
`
`Search Results for: "tocopherol"
`
`INACTIVEINGREDIENT6
`.ALPHA.-TOCOPHEROL
`
`.ALPHA.-TOCOPHEROL
`.ALPHA.-TOCOPHEROL
`
`.ALPHA.-TOCOPHEROL
`.ALPHA.-TOCOPHEROL
`
`.ALPHA.-TOCOPHEROL
`.ALPHA.-TOCOPHEROL
`ACETATE, DL-
`.ALPHA.-TOCOPHEROL
`ACETATE, DL-
`.ALPHA.-TOCOPHEROL, DL-
`
`INTRAVENOUS; SOLUTION,
`CONCENTRATE
`.ALPHA.-TOCOPHEROL, DL- ORAL; CAPSULE, SOFT
`GELATIN
`.ALPHA.-TOCOPHEROL, DL- TOPICAL; OINTMENT
`TOCOPHEROL
`ORAL; CAPSULE
`TOCOPHEROL
`TOPICAL; OINTMENT
`
`ROUTE;DOSAGE FORM7
`INTRAVENOUS; INJECTION,
`POWDER, LYOPHILIZED,
`FOR LIPOSOMAL
`SUSPENSION
`ORAL; CAPSULE
`ORAL; CAPSULE, SOFT
`GELATIN
`ORAL; TABLET
`ORAL; TABLET, EXTENDED
`RELEASE
`TOPICAL; OINTMENT
`TOPICAL; EMULSION,
`AEROSOL FOAM
`TOPICAL; OINTMENT
`
`CAS NUMBER8
`
`UNII9
`H4N855PNZ1
`
`MAXIMUM POTENCY10
`0.064%
`
`H4N855PNZ1
`H4N855PNZ1
`
`H4N855PNZ1
`H4N855PNZ1
`
`H4N855PNZ1
`WR1WPI7EW8
`
`WR1WPI7EW8
`
`7QWA1RIO01
`
`7QWA1RIO01
`
`7QWA1RIO01
`R0ZB2556P8
`R0ZB2556P8
`
`0.5MG
`5MG
`
`0.3MG
`0.2MG
`
`0.002%
`0.002%
`
`0.002%
`
`0.075%
`
`0.08MG
`
`0.002%
`
`0.002%
`
`52225204
`
`52225204
`
`10191410
`
`10191410
`
`10191410
`1406662
`1406662
`
`Update Frequency: Quarterly
`Data Through: September 16, 2013
`Database Last Updated: October 24, 2013
`
`Links on this page:
`1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
`2. http://www.addthis.com/bookmark.php
`3. http://www.fda.gov/default.htm
`4. http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`5. http://www.fda.gov/Drugs/InformationOnDrugs/ucm080123.htm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`7. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`9. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`10. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075230.htm
`
`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies
`
`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Email FDA
`
`For Government For Press
`Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events
`Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive
`
`Links on this page:
`
`http://www.accessdata.fda.gov/scripts/cder/iig/getiigWEB.cfm
`
`12/30/2014
`
`NOVARTIS EXHIBIT 2047
`Noven v. Novartis and LTS Lohmann
`IPR2014-00550
`Page 4 of 4
`
`