EDITION
`
`1999
`
`PHYSCANS'
`DESK
`REFERENCE®
`
`Medical Consultant
`Ron.ald Arky, MD, Charles S. Davidson Professor of Medicine and Master, Francis Weld Peabody Society. Harvard Medical School
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`TRIAL EXHIBIT
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`TX 1374
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`ISBN 1-66363-2...
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`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1092-0001
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`vmRA-TAnS FILMCOATED'
`TABLETS (Pfizer) ••••• , •..••.... • ,' 2427:
`VICKS 44 CQUGH RELmF fPrOct~r
`& Gamble) ....... ' ....... ; ... .-... ,'. ' .... 'IID
`VICKS 44D COUGH & HEAD'
`..... "
`CONGESTION RELIEF (Procter & .
`Gamble) .. , .... .-... .... , .. ; .............. iQ
`VICKS 44E COUGH'& CHEST'
`. '
`CONGESTIC!N,~~t!r,octer.& ,.-
`Gamble), .................... , ... , ........ lID ..
`PEDIATRIC viCKS 44ECOUGH & >
`'
`CHEST CONGESTION RELIEF
`(procter & Gamble) .... • ; ... : .. • .. ... lID
`VICKS 44M COUGH, COLD'" FLU
`RELIEF (proc~er & Gamble). .. .. . • •• IIC
`PEDIATRIC VICKS 44~fCOUGH & ,
`. COLD RELlEF (procter,& Gamble). : lID.
`ORlGINAi.VICKs
`'
`CBLORASEPTIC COUGH AND
`THROAT DROPS'(procter &.
`.
`Gamble) .• .-...... : .. ...• , ... ; ........... JIC
`VICKS CHLOItASEPTrC SORE ' .. '
`THROAT LOZENGES (Practer &
`Gamble) . ....... ,' .: ......... ".,. '.' :,': ,-.lIii:I
`· VICKS CHLORASEPTIC SORE
`THROAT SPRAY (procter & .
`Gamble).: ....... ::.: :::; ....... ,. , ... :;.;. !IC.'
`VICKS COUGHDROPS,MENTHOL: '.
`, " FLAVOR (Procter:& qa'!lble) .• :.,.". III]
`ORIGINAL VIcKs COUGH DR'OPS
`(Procter & Gamble) ... '" ... " ......... .
`VICKSDAYQvIL
`.. ;. ':,,' .:,
`MULTI·SYMPTOM COLDIFLU' .
`RELIEF LIQUID & LIQUICAPS"
`.
`(Procter & Gamble); •• ;' ••. '. ' ... :.:. : ..•
`VICKS DAYQUrr. SmuS . ..
`PRESSURE & PAIN RELIEF .
`WITH mUPROFEN (Procter &
`Gamble).·; .. , ........ : .... ; ..... " ....... lID
`CHlLDfu:i..rS viCKS NYQUn. .. , ... '
`COLD/COUGH RELIEF (procter &,
`.
`Gamble) .. ; ....... : .. .-... ,: .... :.; ........... Ill]
`VICKS NYQtlIL HOT THERAPY.
`(Procter & Gamble! ••• ,.'. '.::. :, .... f' : .... !IC
`VICKS NYQtlIL LlQUICAPS
`:
`. '
`(ProCter & Gamhle) . : ..... ; ; ........ : lID
`VICKS NYQtlIL LIQUID (Procter &',
`· Gamble):; ... :.-, ..... ,.' ................. llIJ
`VICKS srirnX 12 HOUR NASAL .
`, SPRAY AND ULTRA FINE lIUST
`· FOR SINUS RELIEF (procter & "
`Gamble) •. .- , .......... ;'.-•. ,',' ... "': .. : ..... !IC
`VIcKs SINEx NASAL SPRAY AND
`ULTR,A·FJNEMIST FOR SINUS
`RELIEF (Proctu & Gamble) , . .• . . ••. 1m
`VICKS VAPOR INBA.i.EIi (Procter & .
`Gamble) ..• :: .. :", .• , •.... ·.: ....... :,.-..... :.Im
`VICKS VAPORUB CREAM (Procter
`& Gamble) .. ' .. , '.',' : ......... '-' ... ' .• : . .. JIC
`VICKS VAPORUB OINTMENT
`fProcter & .Gamble} .. ' : .. '.' .- ....... '." !IC
`.VICKS VAPOSTEAM (procter &
`.
`Gamble) .. ::.-.. .-•..... ; ........... ; ..... /.. !IC'
`
`110
`
`all'
`
`.
`
`. ;'o'
`'~':;
`~f.
`n:' tl Described In PDR For r.!onpl'e5cripllon Drugs
`iL"
`.
`4·
`
`B""
`BRAN11: AND GENERIC NAME" rNimx . .
`'" '.' . ' .
`• VICODIN TABLETS !KMll
`VlTAFOL SYRUP IEt-erelt) •• •.•• ', .:. ';. 995
`Ver.lpamjl Hydroch]oride Thb]et'.. USP ."'.
`: VlTAFOL-PN CAPLETS (Evereit) <: .. 995
`(WOlson) • ..... .- ....... ,,:. " •.•••• 3216
`.
`. ,·Lab.): .... : •... : •. : ..... :. :'.;' .. '.318; 1486
`Ver.lpami] Sus~ain~ Re! .... Tab]ets
`' . . • VICODIN' ES TABLETS . . . '. ' .:
`. TITAMINA
`(1Ilrmer Chi/co.") ..... .' •• ..... '.' '.,'" 3~1.1.. "(Krioll Labs) .......... ; ...... ,.318, 1487
`, Aquosol A C'p,ulr,. LTSP fAsfro)' • .-:· ••••• 547
`A'lllJ:ioi A P.mmleral (A:,rmi~ <.'> ...... .. 5':8
`·.VERELANCAPSULE.S ~~i . , ..
`+VICODINHPTABLETS
`. . . ,
`'
`(Led.rle Labs) ••••...• , •.•. :.: .. 320. 1549
`(Knoll LabsJ.' •••. : •••. : •. , •..• 318.1484
`· lIlcgadu<c Tablets ,1A,:o) • ...... ; .' ... :" .. 545.
`.VERMOXCHEWABLE·. '.
`.."
`.. '+VIcoDiNTmis:':,
`· Vitatrtist .Intra,Oral Spniy Dietary
`.
`' .. '
`TABLETS (Janss.nJ ... , ......... 3q.1442 ". 'EXPECTORANT"(KlIoll
`..
`,
`· .. Supp.]ements (!>Iay!'r), ... , ".' ....... 1666
`Labs) .. .......... : .; .......... 319. 1488
`. ....'
`.
`VERSED JNJECTION (Roche
`" ReVitaliui" (Mayorr •.• :.:,.: . .' .••• 1666
`'+ VICON FORTE CAPSUr.ES .. .
`Laboratories) ............. " ........ 2720
`. ACES 'Alltio'idaot Soft Gel. (CarIJon), ••• 867
`. (UCB) .••• •••••••••••••••..•. 341,3170.
`VERSENATE. CALCruMDISODIUM
`Laze,crem;; (P.din~l) • ...•• ; ..... : : .. '. 2354
`· .vi.DaYlin ADC Vitamins Drops (fI,ost) • • 2743
`Calcium Disodi",m VOl1iooatelnj.otioD
`'"'.
`'. vicoi>ROFEN TABLETs,
`.
`(3M) ............. ,:. '," .: .'; ...... : 1655
`,r&oll Labs).,: ............. : .. 319. 1489 .
`· Vi·Daylin ADC Vitamins+ Iton, Drop.,.
`.
`
`VEOl$.1J9~.ELJt. 3F .... , ...... IN
`(Ross) • ....... , • ." ..... ': ... , ........ 2743
`.. ~ ..... : .. : .. ' •. 12. 8.8
`VIDARABINE
`. . Vi.DaylinlF ADC VitarniJio Drops'.-: .
`·: :
`.
`,.,
`Vln\.A Opbthalmit Ointmeo~'3%
`AnoU
`. ". . With Fluoride (Rost) .. .... .-... ; ..... 2743"
`VERTIGOHEE'L OIl,U.-DROPS :' ' . • (MOl1ollt'h) .. ........ ; ; , .. ".: .. , .... 1950·
`:Vi.DayliittFADC Vitiunins'+'Iroti,
`. .
`.
`(ll .. /) ..... · .... " ....... : ....... ,; .... ,128.B
`·VI.DMIiNADCVITAMiNs.
`' "
`'. Drop. With Fluoride·(Rossj .••• :--.\ ... : 2743 .
`· VERTlGOBEELTA.BLETS (Heel). , .1288 .
`DROPS (Ros$) . .. :: ..... , . .-; .... : •.. ?743 .
`. . viTAMIN Bt
`.' .. . .'" " . . '.
`• VEsANOID ciPSj.ir.Es .... , .':. .VWAYLIN Anc'viTAMINs+'
`· Mega·B Thb]ets (Arce)-:.'. :'.:.<, .. ," .. ", .. : 545
`.
`. viTAMIN Ii.
`'
`. '
`. mON DROPS (Ross) . .- ........ ; .. ',2743
`(Ro'e'" Laborator~):. ; ... ,.; .. 335.2726
`VWAYLIN MuiTivi:rAMlN'
`.
`.
`'331' 2" 424
`Im!:_
`• VlAGRA TABLETS ". !~er). , •• , . ' . '
`3
`:AIl
`. Meg.-B Thbleis (Arco) .. : . .......... , •• ,545
`CBEWAB~ T. LET!3 (Ross)" ... 2~4
`Vi-rAMiN Bs
`vmRAMYCIN CALCruMbRAL' ..... .'
`. '.. "
`. .
`.
`. VI~~~W~=-r:s ,.' .
`SUSPENSION SYRUP (Pfi2er) •••. 2427
`:"
`·(see.ll1lder: NIACIN)'-
`Vfr.wIN DO
`~os.)., •••• ....... .- "':,' • .' ...... ·•· .. 2743
`•
`,
`'.
`vmRAMYCINHYCLATE.·
`.. , ........ ,
`CAPSULES (PfizerJ. ; ... ,' ..... ;' ... 2427
`VI.DAYLIN MULTMTAMIN
`.
`.
`.
`. , . Beolith Tab]ets (Reach) •.•.•. :: ..•• ;. ,306, 698
`vmRAMYCJNHYCLATE:..
`.'.,'
`DROPS·(Ross) ....... : .... ;: .... :.;.2743.
`, . Lurline PMS Tab]ets·(Fielding): .. : ... ;'.1011.
`. VI-nA'£LIN' l'.ru:i:nVITAMIN':;:., ' .
`JNTRAVENOUS(Pfizer) ........... 2429
`Marlyn Formula 50 CapSule. (Marlyn) •• ·.1666
`Mega.ji"Tablets(Arro) .... , '.:. ,;~ ....• , 5"45 .
`vmRAMYCIN MONOIrYDRATE
`IRON DROPS (Rass) •••• : •. :::. : .. 2743
`~~r?~.~~~~~~~~~ ... , .. :. :2427 ,·VI.DAYLINMuLTriTr~: '
`·Viinmi.t Intra·OmI Spray D;~i.ty .
`. .
`.:
`.
`,
`. LIQUI!? (Ross.!.:., .. , .... ,.,.
`:.'. "Supp]ements (Moyor) •. ·,;,,'~"';: .. 1666
`. Folatin l,wayor/ ........... ::',;':' .: .. '.: 1666-
`.V:I-DAYLIN MUl:rlviTAM1N~ ..
`Vi~otion.S (Major} ...... ....... : 1666
`m01'l LIQtryD (Ross) • .' :.,; "~ .: •.•.. ~743 .
`VirAMiN"B12
`"~ , -',
`. .
`VI~D.AYLlNIF ADC VITAMINS'. ' ..
`, DROPS WITH FLUORIDE: .
`· Bevitamel Tab]ets'(iv"ll~ke).,·.; .......... 3242
`i':.'
`.
`(Ross) •• ~ •• •... : .. :, •• : ••• : •• : ...... 2743
`.
`.
`,
`· C~magen FA Capsules
`VI.DAlliNiF1ADCVrTAi.nNS·~: . . .
`(Savage) . .......... , ........ 336, 2811
`·mONDROPS.WITH· . . . . : " . . '
`Chromagen Forte COpsule.
`. .
`. ' . '
`: (~av(J.g.), •• :.,:, .. :.; ••. ;" .. .', .. :. 336, 2811
`FLUORIDE (RosS).: .'.: •• :.:':;','; .,.; 2743
`'. VI.DATIJNIF MuLTIVITAMIN
`Mega.B'Tab]ets (Area): .. .-: .'; .: ... ,;;. ~545 .
`Nasoobol Ges"!Schwon).,.- ;'.: •.. : 337,2913 .
`, .
`CHEWABLE TABLETS WITH ."
`Niferex,150 Forte Capsules
`: .. :' ,
`. ,..
`FLUORIDE (Ross) .•.•••••.•• "" ••• 2743 .
`.. (Schwarz) .. :,. ; .... ;.,.- "';", • .-331,2916 .
`. VI-DAYLINIF,MULTMTAMIN'+.
`, •. ,.'
`.: 1Iinslcon Cap'liles (UCR) • .- .•. :. ; 341, 3170
`· mON CHEWABLE TABLETS
`.
`· Viuimist Inlm·Oral·Spmy Dietaii .... ,'" ..
`WITH FLUORIDE (Ross), .. •• ,' •••• 2743
`'VI-DATIJNJF MUi.TxviT~ .
`' .
`. Supplements (Mayor).; •.••• ; •• ': .',' ,' .. 1666
`'..
`Bl2 (Mayor) .... j """ ••.. ' ...• ,. ,: ....... .1666·
`DROPS WITH FLUORIDE'
`. .
`.
`(Ros.r ...... ~ ~':>.~.' .. :, ,.:.,:,:,::,. :''- '.2743
`"'., .Folacin'JMayor) .... ' ......... , .... ;.:·1666
`· .' OinkgoMisl(Mayor) ..•• :, .....••. .- 1666
`VI·DATIJNIF MULTIVITAMIN +
`. VitaZo.;(M;.yor): ........... ·: ... ;.:'1666
`mON DROPS WITH . . . , ' .
`· Chronugen Capsules (Savage) ',': .'. ~ .. ~ .2810
`FLUo.~IDE (R,?&S)., ·,'i· 'U' ,." .. ~743
`Cyanocobalanii.:(Vit. BJ:) mjection .• ,".
`VIDEX POWDER FOR ORAL
`'. (Elklns.Slnn) ... ;,' .... , ..... : .. ,';.: ..... 963
`. SOLUTION (Bristol·Myers Squibb
`Fetri. Cap~oIes(Luil.rci».· ...•.. , •..•• '.1649
`Onc%gyl!mmullOl~gy~ .•••••••• .... ; 806 .
`Hemoeyte-F Elixir (U.S.·' . .-
`.'.
`'.' '-" ..
`·VIDEXPED~CPOWDER.
`PluJrmaceuliC<lI) • • ,: .... .- • .; ... ~ •.• ~ .... 3175
`.
`FOR ORAL SOLUTION '.;' ,"
`·N.·lmn Plu, E~xit (MeW.- •• , .... , •• , ·1927
`· (Bristol·Myers Squibb . . . . ". .
`VITAMIN B COMPLEX'
`. OntDlogy/Immunology).·, .• ;-; .. ; ...... 806
`Meg';:~B. Tab]ets (ATf'o) • ••• '.' • .' ••••••• , • 545 .
`..VIDEXCHEWABLE'
`,-:' ,. "
`, . TABLETS ·(Bristol·Myers
`'l1TAMIN B COMPLEX Wrm
`'.
`' . . Squibb. . " . ' , . , .
`vrI'AMINC'
`. pncololfY/.Immu1lfJlogy):;.'.· ••• .. 30~. ~06
`.....
`Cefo] Fi]mtab Thbl~~ fAhbolii.· • • : •..•.. 415
`VINBLASTINE SULFATE
`O.erimed T"ble~·(Fielding): .• ':. ~., .... 1011
`Ve]bai Vi.]'; "(UlIy) .::.:; .... : ... : ::. 1639
`Iberet'Liquid (Abborr). ', •.•..•••• ;: •• ~ •.•. 455
`··lbenii.500Fi]miaiJ·Thbiets·(Abboiij •. :;; • .455
`'viNCRlSmSvLFATE
`.
`.
`Ibetut·500 Liquid (Abhofl) ••• ' •••• •••• ;·.455
`OnonviriSo]ution vial •. &Hyporets .. ,.'
`:' .!beret·Folic·SOO Filmtitb Tablets
`(lilly) •• .. : ............ , .. , ...... 1624
`(Ahbort). , ' ........................ ' .. 446
`.. VINORELBINE TARTRATE
`Meg'dose Tablets (A""') ........ : .. : .... 545
`Navclbine Injection (Gla.x:o
`.
`Nepbro.Vlle:j. F.T~]"ts (R&D) .• .. : •• 2578
`. Wellcome) ••. • · ..... , .... .' ..... 313,1184
`, .- Ne.phro-Vite R':Thb]etS (R&Dj.; .• ;'. ;. ,'2577
`YIOKASE POWDER (Aic.:inJ· ..• ; :.';. ;620
`Hemocyte. f'lus Tabu]os (U.S.
`.
`.
`Pharmaceutical) • ............. " •...•••• 3.175
`.VxOKASET~LETS:iAWrz) .... ~30!;i, 620 .
`Nephro-Vite Tablets: (R&D).',.'; ""." : .• ;·.2578
`, VIRA-A OPHTHALl'd:rt . .'
`..' .
`'vrI'AMINC
`.
`· OINTMENT, 3% (MolWrch) •... .- •.• ~950
`.
`., "
`Chromogen FA Capsu]e, ' .
`' . VIRACEPT ORAL PO~ER
`(Savage} • .. , ......... "' ....... 336, 2811
`'. (AgouronJ ............... : .• : .. 303. 484
`Chromagen FoneCapsule..
`. .
`. • VIRACEPT TABLETS·
`','
`,
`(Savag<) .. ... : ................ 336. 2811
`. ': {Agouron) ..... ....... : ....... , .. 303,484.
`Foro-Folic-500 F.mitab Thb]ets (Abbart) . •• 446
`Fen:>-<;lrad-SOO .F~mtab Tab]ets (Abbotl) • .- .446
`+ VlRAM1lNE TABLETS
`. ' .
`(R(X<cW) .. .'; .......... , : •. , ... 335, 2766
`I"rosp"'-'Cilpsu]es (Fielding).:' •••••.•••. 1011
`lro,paiJ 1hl>lets (Fielding)., •. : .' .••• ; •• 1011
`VIRAZOLE aCN) .. ; ...... ; ... ..... , :1382
`ProHavanol Tablets (USANA) ••••• 341, 3185
`VIRrr,;~N ~APslJLii;s (Sta;); ....• .. 3131
`Trinsicon Capsules (UCR) ..... , •• • 341,.3170 .
`Vi~st Intra· Oral Spray Dietary
`..
`,
`~ON IM,INJECTION (Star) •.••• 3131
`Supplements (Mayar! .. .• : .: .. , ••• 0 .. 1666
`VIST.Ait!L· CAPSULES (Pfizer); . : .. :. '2430
`C'+ Zinc (Mayolj ... .............. 1666
`CardioCare (Mayor) • •. :.' .......... , • 1,666
`'V:tSTARIL INTRAMuSCULAR.: .•..
`SOLUTION (Pfi2er),.:.;· . .••• :. ;.;. 2431
`ACES Antioxidant Soft ·Oe]. (Carlson) . ••• 867
`"visiAiuL O~·.~USP~SION: - ':
`Chromogen Capsules (Savage) ••..• ; •. ~'. 2810
`CitraDerm' FaoiO! Comple~ Cream'
`.
`.
`(Pfi2er) • •••... "', '.'" .', ••.• , .' . .-....... 2430
`. (Pedinal) •.. O:;;: .... ....... '.; •• ;, •• '2353
`··VISTIDE INJECTION (Gilead
`' .
`Fetrin ·Capsu]." (LuitscoJ . ....... c ..... 1649
`ScieMesl •......................... 1079
`. .
`Peridin·C Tablets. (Beurlich) • ••••. .- • .- •••• 734
`. .
`·
`,
`.Vi·Daylin ADC Vitrunins Drop. (Ross) •. 2743
`"vrI'AFOL CAPLETS (Euerett) .•••• ; •• 995
`
`,
`
`.
`
`.
`.
`
`c
`
`.
`
`VITAMINS WITH FLUORIDE/137.
`Vi.Daylin ADC Vitatrtins + Irori Drops'.
`'.
`· (Ro.s) ... ; ..... ...... : .... ,:.-., ..... 2743.
`. Vi:DayiiolF ADC Vitami .. Drops ,..' .. '
`.
`'. With Fluoride·(Ross) • .-... .';., .. ·, ... 2743
`Vi-D.yiiolF Ant Vitamins + lion
`: .
`.
`· Drops With·Fluoride (Ross};;.:, .••.. 2743
`"
`',' . . , '
`VITAMIN D
`ColMag Plus .ThbletS (USANA).: •.• 341, 318S
`· Megedose Tab]et, (A('Co) • •. ; •· ••• ::.: ••• ,545
`·Vitamist.lntra.OralSpray·Dietary
`,
`.
`'Supplements (Mayor), •••. .... · ....... 1666
`Herl>al O'teoCalMag (Mayor) •• :. , :.: 1666
`Citracal Caplets + D (Missio~);, •...• : . . 'i928·
`Vi·D'ylin ADC Vi~;'sDrop. (Ross) • '. 2743
`Vi·Dayoo ADc vltiinin. + Iron Drops
`· (Ross) .. · ..... :.-.;.: ...... :.-., .... 2743
`.
`.Vi.DayiinlF~ Vitamins Drops .
`· With Fluonde·(Ro.s) ......... , ..... 2743
`Vi-DayliolFADC Vitanii ..... In:in'
`,
`Drops With Fluoride (Rois) •...... ',' .2743
`. ... YrrAMrnE
`.
`'.
`, Cefol)~jhnlDb Toilil.;. (Abboir) •••• •.•••. 415
`'Megedose Thblets (Arco) . •.. , .•• " • , •• , 545
`Nulr-E-So] Liquid (Ad"",,~ed .. ' ".
`.'
`Nutril1onal) . •..• : ..... : ....... : .. ~ .... 483
`Unique .E ViIDliun E Capsules (Grace).' • • 1286
`Vitami.t Intra~Oral Spray DietaIy , .'
`Supplemen!S (MlIy~r} .... , .. ...... ,.1666
`· Blue-O';";n Sea Sp,;"y (Mayor), •• , •• ~ 1666
`CardioCmi (Mayorj •.• • ~ .• : ••.•.... ~ . 1666
`E + Selenium (Afayoi).; •. : .... ,', .• , '1666
`· . Revitalizer(Mayor) ........ , •.. , . ~. 1666
`ACES AntiOxidant Soft (;,,]. (Carlso';) •• :'.867
`'Co-QiO (Carlson) ...... ; ...... •• '.:, ... 867
`· E-Gem·. Soft t:;.i. (Citr/sonJ,:: .... : .• : ••• 867
`r.;..tino]-E Creme '(Ped/nol) ••• • :.,; •• ;;:.2354 ,
`i.azerCreme(Pedin.iI). ' .. ;;',,:. ~ .. ."::. 2354
`"
`~ VfrAMrN Kt '
`.
`'. AquaMEPHYTON Injeotin. (MerCk) . . ';.1735
`· .MephYtohablets (Met:cl'). , . .' .: ... ; 323. 1832"
`VITAMiNS, MULTIPLE ' . . ."
`.'
`· Genm.d TabletS· (Fielding);' . • '.-.:',' •. ; ••• .- 1011
`Matero.Tab]ets (Led,rle Labs).:-;. 319. 1522
`, 'Mega Antioxidant Tablets"; ,..:
`.
`..
`(USANA) • •• " ..... , .... ; • i, ... , 341. 3185 .
`. Nephrocap' (Fleming)., .• ~;;'" : .. : ,.;.- .,1014
`,Nephro-Vite Rx Tab]ets (R&D).· •• ~: .••• 25n
`Vit.misf Intra·Oral Spray Dietary·
`.....
`.. Supplements (Mayor), •••••. , .•••••• 1666.
`· Anti·Oxidant (MajOr): .. : ......... ; • i 666
`Pio.Bio Mist PB arid.GS (Mayor)'. : •. )666
`VitaMinophen (Mayor) . , .. ;; : ..... , 1666 .
`Ca]eet Phi,,·1'ab]etS(Mlssion) ••.•••••.. 1929
`· M.V.l.·12 Multi-Vitrunin Infu,ion
`,:
`.
`· . (Asira) ........... ~," •· .. · .. , .... :., •• 575
`. M.V.I .. Pediatric for Infusion' (A~tro).: .•• ~ 575 .
`Nephfo. Vile Tab]ets(R&'D) ..•.••••• ' ... 2578
`Vi'DaY\in Mu]tivitaim. Chewab]e"
`'.
`r.blets (Rost)·" •• y .... .. , .. : ....... 2743
`Vi-Doylin .Mu]tivitomin Drops (Ross) •. , •• 2743
`C' Vi,D.ylin Mu]tivltaminl:.iquid.(Rossj •.• 2743
`:.Vi-DayliolFMoIelvitamin Chewable
`Tab]ets Wilh Fluoride (Rots): •••••••• 2743
`'. Vi-~ylinlF Multiviu,m;n + Iron."
`.
`Chewable Tab]ets With)'luoride
`' . '
`(Ross) .•• ........... : :.: •••• ': • ." .. 2743
`Vi.DaYliolF Multivitatrtin Drops Willi
`.
`Fluoride (Ross) •. ............ · •. , ••••• 2743
`Vi·DayliolF Mu]tivitamin + ItoD
`Drops'With Fluoride (R"st) .... • ' .. : .. 2743
`VITAMINS, PRENATAL'
`,
`' .. Emamil Natnlins Rx Thblets (Mead
`Johnson Nu'rrilionals): •..••• ' •• , .•..• 1692
`Niferex·PN Tablets (Sthwan). : • ; • 337, 2916
`. Nifei-ex.PN Forte T.1i]ei. .
`. .'
`(Schwarz) ..• ................ 337,2917
`·Prew. PrenaJad,'u]ti.VitamiTl!
`.
`Minilral (UCR) . .-.•• ; ..... :':; ••• ; ••• ,3163
`Pre •• te Ultra Thblets (S~nofi) . .... :335, 2802
`Advanced Formu]a Zenate
`'..' . :. .
`Tab]ets (Solvay) •. ............ 340. 3128
`Lactocal.F: Tablets (lAser) ••• ~· •• •••• ;'.: 1509
`Mission Prenatal Tablets (Miss;";') • . : ..... 1929
`Mission Pretiatat FA. Tab]ets
`..
`(MIs.ion) .... ...................... 1929
`Mission Prenai.1 H.P. Tabi.ts . '
`.
`(Mission) .. • : .................. ; •• 1929
`Mission Prenatal Rx Thblets (Mi";ion) • • ; 2 929
`VITAMiNS WITH FLUORIDE
`Infant Fo.rmula Mu]ti-Vitll'1uoride Drop' ,
`0.25 mg (Alra) ......... ........ .... 510
`lIifant Formula Mu]/i·VitlFluoride
`Drops 0.50 Dig (Alro).: • • :.,., .•••. :. 5ID
`· Infant Formula Tri-VitlFluoride Drops:
`.
`· 0,25 mg (Alra).-.. .......... : ... , ... 5ID
`Infant Formu]. Tri-VitlFluoride Drops " .'
`• 0.50 mgJAlral . .. , ........... ; ...... .' 5ID
`Vj·DaylinIF ADC Vitamins Drops
`.
`With Fluoride (Ross) .. • : ......... : ...... 2743
`
`Underline Denotes' GeDerl~ Name
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1092-0002
`
`

`

`PRODUCT INFORMATION
`
`Arco Pharmaceuticals, Inc.
`105 ORVillE DRIVE
`BOHEMIA, NY 11716
`
`For Prevenlive Therapy ?f Tubercul":,si.s . .
`. .
`Before isoniazid prev~ntive therapy IS lrutia~d, bactenolo~
`.•. lly positive or radIOgraphically progressIVe tuberculosIs
`'0,' t be excluded. Appropriate evaluations should be per-
`r,,,,,.,s,ed in Extra pulmonary tuberculosis is suspected.
`d ' . I d
`Oll'
`Adltils Ol'er 30 ~: 300 mg per ay In a sing e ose:
`.
`IIJfants alld Ch,ldren: 10 mglkg (up to 300 mg d9.lly) In a
`Direct Inquiries to:
`single dose.
`. . .
`Professional Service Department
`In situations where adherence Wlth druly preventative
`(516) 567-9500
`thll"apy cannot be assured, 20-30 mglkg (not to exceed
`900 mgl twice weekly under the direct observation of a
`health care worker at the time of administrations.
`ContinuoUS administration of isoniazid for a sufficient pe(cid:173)
`'od oHime is an essential part of the regimen because re(cid:173)
`r.~pse rates are higher if chemotherapy is stopped prema(cid:173)
`t~rIll~~ In the treatment oftuberculos!s, resistant organisms
`ma)' multiply and the. emergenc.e durmg the treatment may
`necessitate a change In the regnuen.
`.
`silllple colorimetrics method 0: chec~ for ,so~azldm ~e
`FOJ' following pa~ent compliance: th~ Potts:Coz.ar~ u:st9, a
`urine, is a useful tool for assunng patient compliance, which
`i. essential for effective tuberculosis control. Additionally,
`j~oniazid test strips are also available to check patient com-
`pliance.
`. . .
`. ,
`.
`Concomitant admlnlstratlon of pyrldoxme (Bs) ,s recom-
`mcnded in the malnourished and in those predisposed to
`neuropathy (e.g., alcoholics 9.lld diabetics).
`HOW SUPPLIED
`Nydrazid Injection !Isoniazid Injection USP) is available for
`intramuscular use in 10 mL vials providing 100 mg isonia(cid:173)
`zid per mL (NDC 0003-0643-50).
`Storage
`.
`Storc at controlled room temperature IS'-30'C (59'-56'F).
`Protect from light.
`Nydrazid Injection may crystallize at low temperatures. If
`this occurs, Warm the vial to room temperature before use to
`redissolve the crystals.
`REFERENCES
`1. Murphy, R. et al: Annuals of Internal Medicine; 1990: No(cid:173)
`vember 15; volume 113:799-800.
`2. BW'ke, R.F., at al: Res Commun Chem Pathol Pharmacal,
`1990; July; vol. 69; 115-118.
`3. Fleenor, M.F., et 01: Chest (United States) Letter,; 1991:
`,lune;99 (6):1554.
`.
`4. Baciewicz, A.M. 9.lld Badewic., Jr. FA,: Arch Int Med
`1993, September, volume 153; 197(1....1971.
`5 .• Jonville, A.P., et al: European Journal of Clinical Phar(cid:173)
`mocol (Germany), 1991:40 (2) p198.
`6. AIllerican Thoracic Society/Centers for disease Control:
`Treatment of Tuberculosis and Tuberculosis Infection in
`Adults and Children. Amer. J. Respir Crit Care Med.
`1994; 149: p1359-l374.
`7. Hoglund P., et al:European Journal of Respir Dis (Den7
`"mrk) 1987: February; 70 (2) pl1(1....U6_
`8. Committee on Infectious Diseases American Academy of
`Pediatrics: 1994, Red Book: Report of the Committee on
`Infectious Diseases; 23 edition; p487.
`9. Schraufnagel, DE;Thsting for Isoniazid;Chest <United
`States) 1990, August: 98 (2) p314-316.
`CAUTION: Federal law prohi~its dispensing without pre-
`scription.
`
`ARCO-LASE®
`(broad pH spectrum digestantl
`
`aTe
`
`COMPOSITION
`Each soft, mint flavored tablet contains Trizyme*, 38 mg.,
`and Lipase, 25 mg.
`*Contains the followiIig standardized enzymes: amylolytic
`30 mg.; proteolytic 6 mg.; cellulolytic 2 ','lg.
`ACTION AND USES
`Indicated for most gastrointestinal disorders due to poor di(cid:173)
`gestion. Flatulence, gas and bloating, dyspepsia, distention,
`fullness, heartburn, or in any condition where normal diges(cid:173)
`tion is impaired by digestive insufficiencies. Arcolase pm(cid:173)
`vides the highest standardized enzymatic activity, plus the
`pmtective action of the widest pH range. Thus it is effective
`throughout the entire G.I. tract. Requiring no enteric coat(cid:173)
`ing, there is assurance ofa positive breakdown of its factors.
`This is advantageous, because quite often patients with di(cid:173)
`gestive disorders cannot digest their food properly, let alone
`hard, or enteric coated capsules or tablets.
`SIDE EFFECTS
`None_
`ADMINISTRATION AND DOSAGE
`One tablet with or immediately fbllowing meals. Tablet may
`be swallowed Or chewed.
`SUPPLIED
`Bottles of 50's. MOC 275-4040.
`
`ARCO-LASE® PLUS
`
`COMPOSITION
`Same as Arco-Lase, plus the addition of Hyoscyamine sul(cid:173)
`fate 0.10 mg., atropine sulfate 0.p2 mg. and phenobarbital
`'Ia gr. (Warning: may be habit forming.)
`ACTION AND USES
`Gastrointestinal disturbances, such as cramps, bloating,
`spasms, diarrhea, nausea, vomiting and peptic ulcer. The
`enzymes correct the digestive insufficiencies.
`Tbe antispasmodic and phenobarbital contribute to the
`symptomatic relief of hypermotility and nervous tension,
`which usually accompanies functional disturbances of the
`bowel.
`ADMINISTRATION AND DOSAGE
`One tablet following meals.
`SIDE EFFECTS
`May cause rapid pulse, dryness of mouth and blurred vi(cid:173)
`sion.
`CON'l'RAINDICATIONS
`This product is contraindicated in the presence of glaucoma
`or prostatic hypertrophy ..
`SUPPLIED
`Bottles of 50's. MOC 275-45-45.
`LITERATURE AVAILABLE
`Yes.
`
`MEGA-B®
`(super potency vitamin B complex, sugar &
`starch freel
`
`OTe
`
`COMPOSITION
`
`Each Mega-B Tablet cOntains the following Mega
`Vitamins:
`B, (Thiamine Mononitrate)
`B2 (Riboflavin)
`Ba (Pyridoxine Hydrochloride)
`B'2 (Cyanocobalamin)
`Choline Bitartrate
`Inositol
`Niacinamide
`Folic Acid
`Pantothenic Acid
`
`100 mg.
`100 mg.
`100 mg.
`100 mcg.
`100 mg.
`100 mg.
`100 mg.
`100 mcg.
`'100 mg.
`
`APOTHECON®
`A Bristol.Myers Sqillbb Company
`Princeton, NJ 08540 USA
`
`J4-49lA
`
`STADOL®
`ISla 'dol J
`(butorphanol tartrate inj~ction, USPJ
`Full prescribing information for the above product appears
`under Bristol·Myers Sqillbb Company.
`
`NOTICE
`Before prescribing or administering
`any product described in
`PHYSIcIANs' DESK REFERENCE
`check the PDR Supplements
`for revised ·information.
`
`ARCO/545
`
`d-Biotin
`Para-Aminobenzoic Acid (PABA)
`In a base of yeast to provide the identified and
`unidentified B-Complex Factors.
`
`100 mcg.
`100 mg.
`
`ADVANTAGES
`Each Mega-B capsule-shaped tablet provides the highest vi(cid:173)
`tanlin B complelC available in a single dose.
`Mega-B was designed for those patients who require truly
`Mega vitamin potencies with the convenience of minimum
`dosage.
`INDICATIONS
`Mega-B is indicated in conditions characterized by deple(cid:173)
`tions or increased demand of the water-soluble B-complex
`vitamins. It may be useful in the nutritional management of
`patients during prolonged convalescence associated with
`major surgery. It is also indicated for stress conditions, as
`an adjunct to antibiotics and diuretic therapy, pre and post
`operative cases, liver conditions, gastrointestinal disorders
`interfernng with intake or absorption of water-soluble vita(cid:173)
`mins, prolonged or wasting diseases, diabetes, burns, frac(cid:173)
`tures, severe infections, and some psychological disorders.
`WARNING
`NOT INTENDED FOR TREATMENT OF PERNICI(cid:173)
`OUS ANEMIA, OR OTHER PRIMARY OR SECON.
`DARY ANEMIAS,
`DOSAGE
`Usual dosage is one Mega-B tablet daily, Or varied, depend(cid:173)
`ing on clinical needs.
`SUPPLIED
`Yellow capsule shaped tablets in bottles of30, 100 and 500.
`
`MEGADOSE™
`(multiple mega-vitamin formula with minerals.
`sugar and starch freel
`
`OTe
`
`COMPOSITION
`
`25,000 USP Units
`1,000 USP Units
`250 mg.
`100 IU
`400 mcg.
`80 mg.
`80 mg.
`80 mg.
`80 mg.
`80 meg.
`80 mcg.
`80 mg.
`80 mg.
`80 mg.
`
`Vitamin A
`Vitamin D
`Vitamin C wlRese Hips
`Vitamin E
`Folic Acid
`VitaminB,
`Vitamin B.
`Niacinamide
`Vitamin Bs
`Vitamin Bl2
`Biotin
`Pantothenic Add
`Choline Bitartrate
`Inositol
`Para-Aminobenzoic
`Acid
`80 mg.
`Rutin
`30 mg.
`Citrus Bioflavonoids
`30 mg.
`Betaine Hydrochloride
`30 mg.
`Glutamic Acid
`30 mg.
`Hesperidin Complex
`5 mg.
`Iodine (from Kelp)
`0.15 mg.
`Calcium Gluconate"
`50 mg.
`Zinc Gluconate·
`25 mg.
`Potassium Gluconate*
`10 mg.
`Ferrous Gluconate*
`10 mg.
`Magnesium Gluconate*
`7 mg.
`Manganese Gluconate"
`S mg.
`Copper Gluconate*
`0.5 mg.
`"Natural mineral chelates in a base containing natural in(cid:173)
`gredients·.
`
`DOSAGE
`One tablet daily.
`SUPPLIED
`Capsule shaped tablets in botUes of 30, 100 and 2S0.
`
`For information on over-the-counter drugs,
`consult PDR For Nonprescription Drugs.
`
`Sandoz Inc. IPR2016-00318
`Sandoz v. Eli Lilly, Exhibit 1092-0003
`
`

`

`PRODUCT INFORMATION
`
`rine System:' Infrequent: diabetes mellitus, goiter.
`EndD,~ and Lymphatic System:
`Infrequent: anemia,
`Hlrn l bocythemia, thromoocytopenia, eosinophilia, erythro(cid:173)
`throlll •
`1opent8..
`- •
`-
`d b ~~-
`'I bolic and NutrItIonal D,sorders: Frequent: e yurd-
`~.t~ Infrequent: gout, hypokalemia, increased creatine ki-
`1l0n, hyperglycemia, weight increase, increased lactate de-
`,
`n~se.
`h ·drogenase.
`1 uloskeletal System: Frequent: bone fracture; Infre-
`"'~'~. muscle weakness, muscle fasciculation_
`qUiD ~us System: Fr£quent: delusions"tremor, irritability,
`IWVsthesia aggression, vertigo, ataxia, increased libido,
`Jl$rl~essnes; abnormal crying, nervousness, aphasia;1n/re(cid:173)
`"'s /. cerebrovascular accident, intracranial hemorrhage,
`QU'''sient ischemic attack. emotional lability, neuralgia,
`~~ess (localized), muscle spasm, dysphoria, gait abnor(cid:173)
`lIlality, hypertonia, h~okinesia, n;uroderma~itis, n";n;tb-
`(localized), paranOIa, dysarthria, dysphasl8, hostility,
`doess
`ased libido, melancholia, emotional withdrawal, nys-
`.ere
`_
`IlIgIDus, paclllg.
`'Respiratory System:, l(req~ent: dyspnea, ~ore throat,
`bronchitis; Infrequ~nt: epIStaxis, p~st nasal. drip, pne~o­
`oio. hyperventi1a:'~n, pul~onary congestion, wheeZIng,
`hypoxia, p~aryngltis, pleurISY. pulmonary collapse, sleep
`apnea, snonng.
`•
`.
`.
`sfn Bnd Appendages: Frequent: pruntus, diaphoreSIS,
`~c<Uia' Infrequent: dermatitis, erythema, skin discolor-
`~tioo. hy'per~eratosi.s, al~pecia! fungal dermB;titis, hel']Jes
`o.ste~ hirsutism, skin striae, rught sweats, skin ulcer.
`;~i~1 Senses: Frequent: cataract, eye irritation, vision
`blurred; Infrequent: dry eye~, glau~oma, earache, tinnit,u~,
`blepharitis, decreased heanng, re~al hemorrhage, otitis
`emma, otitis media, bad taste, COI\Junctival hemorrhage,
`ear bu~zlng, motion sickness, spots. befor~ eyes ..
`urogenital System: Frequent: unnary mcontinenoo, noc(cid:173)
`turia; Infrequent: dysuria, hematuria, urinary urgency, me(cid:173)
`trorrhagia, cystitis, enuresis, prostate hypertrophy, pye!one(cid:173)
`pbritis, inability to e~~ty blad?er, breast.fibroade~o~I~, fi(cid:173)
`brocystic breast, mastilts, pyuna, renal failure, vag1Dltis.
`p05tintroduction Reports
`Voluntary reports of adverse events temporally associated
`.. ith ARICEPT® that have been received since market in(cid:173)
`troduction that are not listed above, and that there is inad(cid:173)
`equate data to determine the causal relationship with the
`drug include the following! abdominal pain, agitation, cho(cid:173)
`Il!C}'Stitis, confusion, convulsions, hallucinations, hemolytic
`anemin, pancreatitis, and rash.
`'
`OVERDOSAGE
`Bouu ••• trategies for the' management of overdose are
`continuallv evolving, it is advisable to contact a Poison
`Control Centar to determine the latest recommendations
`fot the m.n~gement of an overdose of any drug.
`As in any case of overdose, general supportive measures
`Mould be utilized. Overdosage with cholinesterase inhibi(cid:173)
`lora can result in cholinergic crisis characterized by severe
`Musea, vomiting, salivation, sweating, bradycardia, hypo(cid:173)
`~l19ion, respiratory depression, collapse and convulsions.
`fncressing muscle weakness is a possibility and may result
`
`in death if respiratory muscles are involved. Tertiary anti(cid:173)
`cholinergics such as atropine may be used as an antidote for
`ARICEPT® overdosage. Intravenous atropine sulfate ti(cid:173)
`trated to effect is recommended: an initial dose of 1.0 to 2.0
`mg IV with subsequent doses based upon clinical response.
`Atypical responses in blood pressure and heart rate have
`been reported with other cholinomimetics when co-adminis(cid:173)
`tered with quaternary anticholinergics such as g1yoopyrro(cid:173)
`late. It is not known whether ARICEPT® andlor its metab(cid:173)
`olites can be removed b