`2W
`Pt-lYste
`DESK
`REFETìENEE
`
`@
`
`Senlot Yloo Pi€cldont, Dlnoto¡f søvlccs: Paul Walsh
`
`D|]!ûtoa ot P.oû¡ci ilar|gomollï Mark A. Fl¡eúnan
`Alsoclrtc Product ¡lür4or: Btll Sha(Ei¡nðssy
`
`Flllonslal Aralyoü Wayne M. Soltls
`Dlr€ctor of Sde.! Dlkran N. Barsam¡ân
`Natlonel Sâl€s Mam¡þr, Pïamåceutlc¡l Sdr¡: Anthony Sorce
`Itatlonal Accoünt fulmagþr: Don Bn ccoleri
`S€nþr Accot¡Dt Mrnaeþc Frank Karkowsþ
`Aêcomt Managoll:
`Madon Gtãy,.RPh
`Lawrence C. Keâry
`Jeffrey F. Pfohl
`Suzanne E. Yaíow, RN
`E€ctrllllo Selcs Accoùnt ilaragcr: StephBn M. Sllr€rb€rg
`ilr(onal sdsû mfué¡rr, Mêðcd Ecfiqnþs Trado galo8: Blll Gsfhsy
`Dlrgctor of D¡rüGt ltladcttlEl Mbha€l Bennett
`]¡gt ond Prodrctloí Ëla¡ngier: Lpraine M. Lo€ning,
`6ôû10r Mr.kãthÉl Analt.t: Dina A. Maeder
`
`Dltcolor, taw Botlnca¡ Doueloprnont srd
`Ptoúttslo¡d Su¡port Sarvlcc!: Mul-<esh MeMa, RPh
`Mqr.tþt, Dng llúormdlon gónlcoô: Tnom€s Remlng, RPh
`Dn¡g lnlollî¡don Sprcldhe Mårla oeutsch, MS, RPh, CDE
`Btltorr Dlroctory ¡lsrvhis: Dsvid W. Siftoà
`:
`Scnlor Assoclrtê EdltoÍ Lori Munay
`¡tlßctor o{ hucüon: Cârde $ll¡ams
`ìla¡afþr'ol fttoú¡ú{on: Klmberly H. Vùas
`SGnþr Prod¡ætlon Coordlnator Amy B, Brooks
`Prodrcl¡on Coordlmtoð: G¡annâ Carâ(þnna, Mar¡â Volpatj
`Dslr manaßþE Jeffrcy D. Schaeler
`Sanlor Foí¡at Edltoc Gregory J. Westlay
`,núor E4tol¡: Johânnå M. Môzur,.Roben N. Woemer
`Art åsçocletë Joän K, Akelind
`sÓlrh't.Dtsltal ¡ma5|l{ Coorür¡åtd: Shdrvn W. Gahlll
`Difltel ln$l¡g CooIúlnatoc Fraiìk J. McElroy, lll
`
`R¡mllmcilt Ìlan¡g.n Stephàflie DeNard¡
`
`-oynn" t ao* ard publbh¿d ùy lt¡l€dlcal Edþlnlcs cdrpany, lG I Mqtwls, NJ t¡ô45*17{2. ÂI rbbts twrEd
`my
`Çl
`r
`be rcgrcdrGd, sloEd h e f€trlml s!õtd¡, EB{t4 ßdbtrÈ{iql, d tnMfbd h Ârry bm or by sry msF (ol€don¡o,
`t
`-
`ollÞrube) wfthord Ùb Þrlor wúüâì påmbsl¡n ol ¡tp publbisr. PHYSICIANE OESK REFEREIT¡CP. POF, PDn Fq OphùElnolo0É. P6lGl PDF., and llr PDB, Fmfy
`fadarulG 6€d hsß'm undår lbere. PDH Fd t{drpDtaiflhn OrugE rd Dlsàry Sçplsrmnbfl, PDB Cqrpsnþn Ouldârr,
`to PlMiptin OIwErt cE r€fÉls€d
`Gdd€
`PDR' kr l{àbtl Mêdft*En, PDFi Medcâl l}lclionilyn, PDF Nr¡r¡e's Drug }bnrñool(", PDfil NuEe! D{ddrsyn, 'Iñ6 PDn. Fårl¡ly Gulde Erq|dopedâ of Medbal
`Cæil, Th€ PDFP Ffl¡y Guld6 lo r¡atural !¡l€dhtË ånd lþ¿llng nEËpiærr, fto PDFi Fsrdt 6dó to CofimH AtrFñEû, 'Iùe PDtr Fdm{y Guldg to OvsrttÞ
`Ceds Dn gsN, ånd PDF EþctDlìlc LbfsryrÈ åru |rsdenarl€ wd her*l unûr tbsH.
`Oñ€E ot M.dlel E¡!æíút¡ êoîIs$ PfesiúÊd drd Ch¡el FÆcrn¡uê Otræ: Cuts B.
`t4ca Pjëiþrf, tlel{ lfrrsl L Su¿ônnö 8€D6ll; ybd Prèsdr¡rt, Cñrtr¿ê Huf,t¿Õ
`Résøffi: Psffila M, Bllarlì,' t4æ B?9Ëef,l xtd ci¡cl lnffii
`O/Tñâ: Stær M. BGsslêr; Cìi€f tnffdål Oltosn ChnsþdB Csrldl; Væ Presidona aíl Cúltrgilq Êdry
`^llen;
`GEf : Vlæ PÊdûilç ì14 Buê¡ræ Pbnf,lry;Lhú G. ilope; t4bo Aesid¡nt, tustßîs þft.Ûtut: Ihvld À Pilhr; t4.¿ PrEid$t, FrMæ,. Dooæ SÐtåtd¿: sgilq Væ P¡osktêot,
`tÌteê¡oty Sqíw PEti WàlEh; tutþr Væ Prasldê¡r|q qpeEtlors Jonn Ê. Wbe ; Scnlü Vb h€sl&nL
`,nMcl Sfraac¡r's: Royûlond Zælbr
`@
`
`ISBN; 1-5&?693302
`
`AMNEAL 1026
`Amneal v. Endo
`rPR20l4-00360
`
`
`
`GONTENTS
`
`fi5
`J5
`Þs
`}raoo
`
`ils,DEsrfREFEREvcE
`Shott,rs'¡iacñ manufacturer's
`
`ilanufacü¡rets' lndex (Wh¡te Pages)
`Sec,tlon 1
`,,:fr¡':"
`ptoducts
`Brand and Generfc llame lndex (Pink Pages)
`Sectlon 2
`G/veg tà€ page number of eæh ptoduc| by brand and generic name.
`Produc{ Gategory Index (Blue Pqges)
`Sectlon 3
`Usts all fully describd ptoduct: by prcscilb¡ng category. An oveuiew of the he¿*l¡ngs
`apæàts ôn pqges 2Ol and 2O2.
`Product
`Sectlon 4
`Presen¿s tulrcoron ectuàto,ke qhotos oltabtêE and capsutes, prus ptcturcs of a variety of otiár
`dosaE]e foms and packagles. erangu¿ øpnúaøtyîv-runrn*r*- ,
`Product lrformaüol (white Èqgest
`Ssctlon 5
`The marn sect¡on of the booh.' tncrudae:entries fot over 3,2N ph*mæautrcars. Listtngs are
`aranged alphabèttcally by manufætuer.
`Dla¡lhosüc product l¡úormdon
`Soctlon I
`
`Gulde lera¡1
`
`:
`
`1
`
`101
`
`204
`
`301
`
`tnL
`
`334S
`
`
`
`Deæe rlw by 2õ% wor if ¡o
`ådvoru etrgris æ prust. Rdhsl
`sêM @nøtratio åfur 3 d¡ts to
`gùido furths dß¡go Eqiustóet.
`gkip nô¡t d@ úd d@æ
`suboequeot dw lt læEl 25* ev€n
`if Do cdv@ ôf9cþ æ 9ñL
`Rôd¡sL úeruÐ ñoMb¡lioD r-ñÁr 3
`dÀy6 to guíde Í¡rthr dæEge
`a4iuÉtEút. ItryEptoDàtic,
`t@ttunt i6 i¡di€t d (æe
`Iþmn¡rd¡tbu û¡ dwqíc
`overdmge).
`'[þat m¡doso æ ¡Dd¡qt¿d (@
`mnmrlctiffi
`for chmníc
`¡f th@pbyllina lr
`wrddå8€),
`erbrequatly ræued, dwæ
`doe hy ¡t leút 50S ùd ¡ochæU
`m @ÞtNâtí6 r.ft¡r 3 dtYs t0
`ßuide tunhor doe¿ge edíutÐoL
`ild/o. ru
`thæDüylliæ oGDt¡stim
`ind¡qtêd vbÐwd ¡dvæ oftctd N
`ü¿
`
`Ís ¡d¡led o¡
`
`oxYooÍullr{o
`u +
`(oxycoDof\tE l{cl coillnotu}nElE^sÉl rABLÊTs
`10 mg ãt mD lo ing à0 mO
`
`Hg,
`
`b¡úhm¡'HCr rtrl sl S3
`flre ùenic¡l fouul¡ is 4, ÍsDory-r+hy¡lrut-3'uetù{ry'
`
`ffi "J;äiff ää#Lä*ïs"ö;d";äi;;;ä-
`mtratiotr ed ilwtrE
`ftlqudcy of dosèFl¡lêd oPio;d
`¡dveæ éx¡pi.ne¡ ruù ü ¡auæq @iting, CNS eñærs
`¡¡d ærpiñ¿ory dop¡euio ln opioùd.tolemt patisnls, thc
`situ¡t¡oo is lttéred by th.E devolopoent of t¡lqÂ@ to
`opiokl'nlated rldo efætr, ud the nlotimehip h porþ u-
`deelood.
`A¡ witb 6¡l opioirb, tbe d@ Eut be io¡lividu¡lized (sse
`DOSÀOE AlìlD ADM¡MSTnIIIION), beca@ tl¡e eflective
`r;st!ëio d0É tor su pati€nt¡ wlll be tæ high ùo be tolõr'
`it d by ot¡.r Drdmts
`pltÂRÀta@l0ilEflcs AlÐ MEfASot¡sM
`The activity of OI(YCOI{TINO (o¡yctitone þdrcchloride
`@t¡olled.ñ¡¿@, t¡bl¡f! iA ptiúaÍtt due to thÊ Parobt
`&us oryEdtr. OXYCONIIN t¡bleu an ds¡t¡¿d to prc'
`vüle oo¡ollod delivery of o¡.tedoDe oer 12 bom, Ory-
`codàE ¡6 wtÙ ñberbêd ñoü OX{COMIN t¿bleûÁ wit}¡ u
`
`{00
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`or 60ll
`
`ltbsrptíoø
`À¡out 60rt ¿o 0?ß 0f E q¡ì dæo qf or!@done @ches lÀc
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`Fr.d?fulr Domp!trY
`cÎ 068É0€nt0
`Or08ô, 190t th€ Pudua Froderiù Cupoy
`NuDboE ,1,366,310
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`¡^ Pld,uìl ldentif@lia^ Guìtu' p!8. Aî3
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`Éouc¡nor¡¡" m¡rc¡nr
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`Prcr@l Sh4!¡ (00PS??) r pssÞ (pad of 26)
`to pby6¡ci@, nrrc ed phmæi¡t¡
`
`Purdue Pharma L.P.
`IOO CONNECTICI'|T AVENUE
`NOnIVALT( GT 0688rL3s9O
`
`lnqulrl¡*
`
`E¡Odffi6l
`
`S.rùÐr
`
`80ù877.8210
`
`EßA¡II PATE fTE OT{LV.
`CLIMCTT PEANTACOI,(IGY
`
`mqt¡lì¡
`
`:
`
`bFø%
`+rw+ÐE+{d+frhb
`+hÉrS
`
`8d edåaù
`
`I h€|tr).
`
`of ¿lioiution of
`
`hous of
`
`due ùo ùy¡cíe in qe¡dø ¡ilutiø.
`Eúuqnt djrùillad. otd orlw $núlrn4vúL
`Oryodm ew e ¡siludion in motiliþ mirtrd vith u
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`fonNi¡f fo
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`MelalplitÃ
`
`Tabletó+ lirtiag uder lÎu Frdw trïedæ.
`26
`
`tdøL
`fu sith rn oDioidr, tte EiDiD@ rf.atiw Dl¡¡u m@'
`
`Ucdug ùdù The Ardu Flqld.ick
`
`lirtlna qÂdèr Tàe P¡¡du Fpdsick
`
`lietiog uoder Tle Pl¡du F¡o¡le¡i¡t
`
`DOF
`
`pr.ga ZI
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`qDql¡¡lloq¡, frc u¡lgulc ¡ctMty pnfilc of otlrcr ¡e
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`Øndnu'd on ¡lüi Pcgo
`c{¡dk 2ooo ?01i. ¡If¡D¡ù m¿taÐ.dïbD fd úíiot
`
`
`
`2538/PURDUE PHARMA
`
`T¡bl. 1
`ltfe@ î% Mñciqt uuidtìoLl
`n€ginery'
`Dqage Fm
`
`Single D@
`I0 Ds OXYCONf'IN
`
`20 DgO)(YCO¡¡Ì]N
`40 n¡ OXYCONTIN
`
`80 ns OXICONTINT
`
`Mult,ipl. Do@
`l0 ngOXYCOMN
`TûbleLq ql2h
`5 Et ¡mmsdisb
`rch@ q6h
`
`AUC
`(ng.¡t7*n
`
`r00.? t26,61
`
`207.tr [35 9ì
`
`423.1 133.31
`
`1086,6 f32,3)
`
`103.6 198 6l
`
`09,0 130.21
`
`PHYSICIANS'OESK
`
`r"h¡
`
`10.6 120.il
`
`2r.4 136.61
`
`39.3 [34.01
`
`98.5 [å2.1ì
`
`1ö,1 t31.0t
`
`16.5 f28.81
`
`ä,,U
`
`2.7 144.il
`
`3.2 16Í.91
`
`3 1 l?7.41
`2 | lã2.ii
`
`3.2 169.51
`
`1.6 149.7,|
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`PRACÂUUONS
`
`oxyødoæ in diaiøl poPu-
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`aod all opio-
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`DTN RæUC D6O
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`{EE)
`orycodonc (ng)
`l0 (lxro mg'
`5
`20l.2x10n*,
`s
`
`G¿mro4: mide¡t¡l injory, chert psin, facial edeu, nol-
`0s, D6k DaiD, paiD
`Cordì/.wu/ø.r: øigmine, synopo, vàrodilation, 6T do.
`pE$¡m
`mcl¿tíon, llsh¡le¡æ, g8¡tNintÆti_
`app6tiòe, ¡duu a¡d wmitiDg, .tG
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`DAUG ABU3D.AND DEPENITENCE (¡lddtor¡d,
`
`tio¡
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`Cavmion fm Fivd.Ratio Opitid I ApAp, ASt\ o¡ NSAID
`Conbinoliu Drug.
`
`¡ilo efects.
`
`tq ¡ohim
`d@-UEiting
`
`Ì¡blo 3
`
`o,q@¿o¡e
`,
`Codoino
`0.16
`F.arrqyl TTS
`SEE IELOW
`nYüñdono
`0,9
`nsnrO
`7.5
`0.1
`115
`0.6
`
`olitd
`
`gEB BEI,oW
`
`t¡l
`OÁ
`3
`g
`
`'Tg b. ú.d mly tor æ¡mlon to qd oryædon¡. þo u_
`oo¡h twÍvi¡t h¡glhd@ porettorat opioids, a mon ciu_
`
`
`
`oxYrRo
`loxyædm hVdrodilo¡tdal
`lmm.dl¡lô{doM Or¡l C|F.ulÉ
`6mg
`oxYl sfn
`(oryodm hydrochlorldcl
`lmmrdlltàB.lGu
`Orcl COt{GEfl lnATÊ 9olet¡,otrr
`20 ng/lrùL
`.Tha¡ pro4¡C EnLi[ dry dMnl rqbbd
`DÉCN¡PNON
`
`G&
`
`@B
`
`ox¡odme fu a4r indMdql pti6t Esy inææ with re-
`pÊrt¿d doslng dw to ù inææ i¡ DdÀ ed/ü the ddôÌ.
`opDcût oftolé¡åtrcê.
`Coß.Flr¡t¡oî-Adv.ru Erp..¡.M Rdt¡oôtiípa!
`OrçrIR Capeuhr rnd O.tF¡gI CONCEM-III{IE Solution
`
`, ! wbiie od6l@
`Che opiu alkr.
`by the folìoviag
`
`i¡dividu¡lÍr¿¿ (e
`b€
`), beqw tùs efective r
`b3 tæ hich ùo bc bleÞ
`
`INDICAUONSÂND UsÀCE
`h¡ tùe ælief of nodemto ùo ¡þdeÉtelj, seê prir.
`co¡mnâ¡NDIcÂTll)N8
`OxyFÀSI i¡ o¡tninrlicrtod in pÂtisqt¡ vit¡
`Ory¡B
`l¡o*n
`t¡
`o¡ lE ùy
`situatim
`æ
`wh¡o
`includec
`¡ndæLs
`rith
`tEoÀltarcd 6ât-
`ed pa-
`o¡
`l¡ eru pôlidrt
`ileu¡,
`
`øævæ bonchi¡l
`f,ho b{¡ u iB ¡ulp4lad of haviag pudytic
`WARI{INGS
`
`WR Orrl c.p{lø
`E¡ah 6 Dg of O¡yIR C6psul4r ût¿iÀ¡:
`
`O¡VfAEl Oñl CO||CCNIÌAIE Sotudon
`Eaù 1 oL of O¡yfAST Cono¡rt¡¡to Solution mt¡i¡s
`20 ûE
`odim
`ter
`
`^cnoNs
`îbe anrþric in!ædiut, o¡J@doæ, iE a æD¡¡y¡ùholic r.
`@tic wlù Dultþle aclioos qual¡todvely riE¡lù to th@ of
`oorphine; tho moot pmlHt of rha iÂvolv€
`th¡ qF¿l
`¡@tll mosle. Tha
`f orytodmo æ ul
`
`CUMCÂL PTT¡RMAODI¡GY
`
`30 (3x10 ng)
`{0 (2x20 n8)
`60 (3x20 ng)
`ø0 (2x10 ßg)
`1r0 (3x40 ¡8)
`160 (2x80
`ms)
`ilo (3x80
`ûc)
`,/ui¡/.noæ øf Íhñp!
`
`10
`10
`l6
`20
`30
`40
`60
`
`blish fEin @rtñ,I. TtE d.thod of
`osd ¡bove shodd be onlofed.ø
`¡lly lor nq,qq
`lnin ¡!a.
`fot aoud.lhælæk oloid
`(a.r., êwry 6 to l,
`Êriodi€lly
`
`Dútbs) I apprcpliato.
`Cædtiø of Thafrw
`9âø tåe pation
`CoNTIN teblsts,
`ruwelly hare
`ddfút. Ho*rvar,
`dl d¡JrE to pryent òittre ård symptsÞ d withdnwal in
`là¿ plvli€lly d.peDdqt psaiet. 'tbç d¡¡lJ' dæ ¡huuld be
`¡oduæd ùy appuin¡l¿ly 6M fot th{ 6ñt two d¿y!.qd
`üø ¡lduc¿d by 26ã ov€ry ¿wo d6yr üherølì¿¡ util ûB fo
`t¿l dæ€ èeche¡ the dæ rummended for oploid raive pÂ.
`¿ir¡b (10 of 20 mg qLlh), IllebDy N then b¿ dísnti¡.
`utd,
`
`Co¡wion ltø OXY@Ì{TIN to Pmît4to¿ Opìõidô
`
`¡poM,
`9AFÎY ATIID HAIIDUNG
`
`üOWSIIPPüED
`OXYCONTIN@ (rycodone hydræhlorido ø¡t¡olled-e
`l$e) r0 Dg teblets æ rcud, l¡¡mæ4 wh{tÞøtoßd_
`thè ryúbol OC 6 one side drd l0 o¡
`anvd tablotÁ b€Âr¡ng
`tlr¿ othe¿
`'lloyæmppùcd úfollwst
`I{DG 690t¡.r00.10: child-rui¡t¡ot clo8w, opaque plastic
`ùolde of 100
`
`taDC 6901t'108-l0r child-ei¡tont cløuê, opsque plâ¡Uc
`boftld of lm
`
`ido t{rybn Md to €lsclliEl ôt¡nul¡lim,
`
`tåls drug, ud
`wlth tbe i¡e
`otü€¡ oEl
`
`and ¡dnìnistered
`lo thr w of
`otrer 4
`dnlgh rtlìjst
`to tho fed-
`
`Àedlcål¡o¡â,
`
`The¡r ere euppli6d o follvo:
`tltDg 590U-t05.10¡ cìild-¡æi¡tant ctorure, opaqw pl.eetic
`bott¡€¡ ol l0O
`
`G!.Íolnta¡lo.l l?rqt rñd Otht Smooù Mc.dc:
`
`''Db¡ew tn d¡!ht, Iight-ruist¡nt cmt¡ùü.
`cAUnoi¡
`DC^ orúr fîrú n.$¡Þrd.
`ir Ooly
`Mouf¡¿urcd by tbe PF l¡bontorie¡. I¡c.
`Ìbbr¡. NJ.07612
`Dirhibutcl by purdw ptma Lp.
`Nmra¡t, Cf OOOOO3SSo
`
`E¡ L.P.
`{,9?0,016; 5,266,3A1;
`
`Jw 16, t99B
`a4goÈBL
`' Èløwn in Prcdtct ld¿naíßaøtìol Caid., page gg3
`
`Pnßcal,!troNÊ
`S¡r&ul làæouirru Ìo¿ordins OTJEAS7" Orcl CONCEN-
`TRÀTEfumgll mLSolutìut
`
`CorrtlÂu.d ü n.xt pagc
`Cof!¡* 200 0 P0ñ {rllffit¡ ùd inw .4tü6lq m¡{oo
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`