throbber
PHARfll1ACY UBRARY
`UNIVERSITY OF WISCONSIN
`APR 1 5 ZOOZ
`
`Madison WI 53705
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 001
`
`

`
`EDITION
`
`2002
`
`PHYSCANS'
`DESK
`REFERENCE®
`
`Executive Vice President, Directory Services: Paul Walsh
`
`VIce President, Sales and Marketing: Dikran N. Barsamian
`National Sales Manager: John A. Schmidt
`National Sales Manager, Custom Sales: Anthony Sorce
`Senior Account Managers: Marion Gray, RPh; Frank Karkowsky
`Account Managers: Lawrence C. Keary; Eileen Sullivan;
`Suzanne E. Yarrow, RN
`Director of Trade Sales: Bill Gaffney
`Associate Product Manager: Jason R. Springer
`Director of Financial Planning and Analysis: Mark S. Ritchin
`Vice President, Clinical Communications and
`· New Business Development: Mukesh Mehta, RPh
`· New Business Development Manager: Jeffrey D. Dubin
`Manager, Professional Data Services: Thomas Fleming, PharmD
`Manager, Concise Data Content: Christine Wyble, PharmD
`Drug Information Specialists: Maria Deutsch, MS, PharmD, CDE;
`Anu Gupta, PharmD
`Editor, Directory Services: David W. Sifton
`Project Manager: Edward P. Connor
`
`Senior Associate Editor: Lori Murray
`Assistant Editor: Gwynned L. Kelly
`Director of Direct Marketing: Michael Bennett
`Direct Mail Managers: Jennifer M. Fronzaglia, Lorraine M. Loening
`Senior Marketing Analyst: Dina A. Maeder
`Promotion Manager: Linda Levine
`Director of Production: Brian Holland
`Senior Data Manager: Jeffrey D. Schaefer
`Production Manager: Amy Brooks
`Production Coordinators: Gianna Caradonna, DeeAnn DeRuvo,
`Melissa Johnson, Christina Klinger
`Index Editors: Noel Deloughery, Shannon Reilly
`Format Editor: Stu W. Lehrer
`Art Associate: Joan K. Akerlind
`Digital Imaging Supervisor: Shawn W. Cahill
`Digital Imaging Coordinator: Frank J. McElroy, Ill
`Electronic Publishing Designers: Rosalia Sbema, Uvio Udina
`Fulllllment Managers: Louis J. Bolcik, Stephanie Struble
`
`MEDICAL ECONOMICS Copyright 0 2002 and published by Medocal Economics Company, Inc. at Montvale, NJ 07645-1742. All rights reserved. None of
`-------3~-----_ the content of this publication may be reproduced, stored in a retrieval system, reSOld, redistributed, or transmitted In any form or
`by any means (electronic, mechanical, photocopying. recording, or otherwise) without the prior written permission of the publisher.
`THOMSON HEALTHCA
`PHYSICIANS' DESK REFERENC~. PO~. Pocket PO A", The PO A" Family Guide to Prescription Drug~. The PDR• Family
`R E
`Guide lo Women's Health and Prescription Drugs• , and The PDR" Family Guide to Nutrition and Heallh" are registered trademarks used herein under license. PDR for
`Ophthalmic Medicines'"'· PDR for Nonprescription Drugs and Dietary Supplements'"· PDR Companion GuideTM, PDR Pharmacopoeia'"' Pocket Dosing Guide, PDR' lor
`Herbal Medicines'"'• PDR• lor Nutritional Supplements' .. , PDR" Medical Dictionary' ... PDR" Nurse's Drug Handbook'"', PDR" Nurse's Dictionary"". The PDR* Family Guide
`Encyclopedia ol Medical Care' " · The PDR" Family Guide to Natural Medicines and Healing Therapies'"· The PDR" Family Guide to Common Ailments' " · The PDR" Family
`Guide to Over-the-Counter Drugs'"· The PDF!" Family Guide to Nutritional Supplements'"· and PDR" Electronic Ubrary'" are trademarks used herein under license.
`
`Officers of Thomson Healthcare: Chief EXOCU!Jve Officer: Michael Tansey; Chief Operating Officer: Richard Noble; Chief Financial Officer and EXecutive Vice Presldenr. Finance:
`Paul Hilger; EXecutive VICe Presiden~ Directory S6ntices: Paul Watsh; S6nior VICe PreskJent, Ptannmg and Business Development: William Gole; VICe President. Human Resources:
`Pameta M. Bilash
`
`ISBN: 1.56363-4U-2
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 002
`
`

`
`FOREWORD TO THE FIFTY-SIXTH EDITION
`
`Welcome to the 2002 edition of PDR. With over 3,000
`pages of detailed prescribing information approved by the
`FDA, this volume is unquestionably the healthcare com(cid:173)
`munity's most fundamental pharmaceutical reference(cid:173)
`an indispensable source of in-depth data on the efficacy,
`potential adverse effects, clinical pharmacology, and
`proper use of thousands of prescription medications.
`
`For complicated cases and special patient problems,
`there is certainly no better resource to tum to. In routine
`situations, however, a synopsis of the most important
`facts will often suffice. For just such occasions, PDR now
`offers the PDR PharmacopoeiarM Pocket Dosing Guide.
`This handy little book can accompany you wherever you
`need to go, around the office or on rounds. Only slightly
`larger than an index card and a half-inch thick, it fits eas(cid:173)
`ily into any pocket, while providing you with FDA-approved
`dosing recommendations for over 1,500 drugs. Unlike
`other condensed drug references, it's drawn almost exclu(cid:173)
`sively from the FDA-approved drug labeling published in
`Physicians' Desk Reference. And its tabular presentation
`makes lookups a breeze. At $9.95 a copy, it's a tool you
`really can't afford to be without.
`
`Recently, the use of over-the-counter nutritional supple(cid:173)
`ments has sky-rocketed, and PDR has responded with a
`brand new medical reference covering this unfamiliar(cid:173)
`even exotic- set of agents. Entitled PDR• for Nutritional
`Supplements™, it offers the latest scientific consensus
`on hundreds of popular supplement products, including
`an array of amino acids, co-factors, fatty acids, probiotics,
`phytoestrogens, phytosterols, over-the-counter hormones,
`hormonal precursors, and much more. Focused on the
`scientific evidence for each supplement's claims, this
`unique new reference offers you today's most detailed,
`informed, and objective overview of a burgeoning new
`area in the field of self-treatment. To protect your patients
`from bogus remedies and steer them towards truly bene(cid:173)
`ficial products, this book is a must.
`
`For counseling patients who favor herbal remedies, anoth(cid:173)
`er PDR reference may prove equally valuable. Now in its
`second edition, PDR• for Herbal Medicines™ provides
`you with the latest science-based assessment of some
`700 botanicals. Indexed by scientific, common, and brand
`names (as well as Western, Asian, and homeopathic indi(cid:173)
`cations) this volume also includes a Side Effects Index, a
`Drug/Herb Interactions Guide, an Herb Identification
`Guide with nearly 400 color photos, and a Safety Guide
`that lists herbs to be avoided during pregnancy and nurs(cid:173)
`ing and herbs to be used only under professional super(cid:173)
`vision. Although botanical products are not officially regu(cid:173)
`lated or monitored in the United States, PDR for Herbal
`Medicines provides you the closest analog to FDA(cid:173)
`approved labeling- the findings of the German Regulatory
`Authority's herbal watchdog agency, Commission E.
`
`To maximize the value of PDR itself, you'll also need a
`copy of the 2002 edition of the PDR Companion Guide™,
`an 1,800-page reference that augments PDR with a total
`of 10 unique decision-making tools:
`
`· Interactions Index identifies all pharmaceuticals and
`foods capable of interacting with a chosen medication.
`· Food Interactions Cross-Reference lists the drugs that
`may interact with a given dietary item.
`· Side Effects Index pinpoints the pharmaceuticals asso(cid:173)
`ciated with each of 3,600 distinct adverse reactions.
`· Indications Index presents the full range of therapeutic
`options for any given diagnosis.
`· Off-label Treatment Guide lists medications routinely
`used-but never officially approved-for treatment of
`nearly 1,000 specific disorders.
`· Contraindications Index lists all drugs to avoid in the
`presence of any given medical condition.
`· International-Drug Index names the U.S. equivalents of
`some 15,000 foreign medications.
`· Generic Availability Guide shows which forms and
`strengths of a brand-name drug are also available
`generically.
`· Cost of Therapy Guide provides a quick overview of the
`relative expense of the leading therapeutic options for
`a variety of common indications.
`· Imprint Identification Guide enables you to establish
`the nature of any unknown tablet or capsule by match(cid:173)
`ing its imprint against an exhaustive catalog of identify(cid:173)
`ing codes.
`
`The PDR Companion Guide includes all drugs described in
`PDR, PDR For Nonprescription Drugs and Dietary
`Supplements™, and PDR For Ophthalmic Medicines™.
`We're certain that you'll find it makes safe, appropriate
`selection of drugs faster and easier than ever before.
`
`PDR and its major companion volumes are also found in
`the PDR• Electronic Library™ on CD-ROM, now used in
`over 100,000 practices. This Windows-<:ompatible disc
`provides users with a complete database of PDR pre(cid:173)
`scribing information, electronically searchable for instant
`retrieval. A standard subscription includes PDR's sophis(cid:173)
`ticated search software and an extensive file of chemical
`structures, illustrations, and full-color product pho(cid:173)
`tographs. Optional enhancements include the complete
`contents of The Merck Manual Seventeenth Edition,
`Stedman's Medical Dictionary, and Stedman's
`Spellchecker. For anyone who wants to run a fast double
`check on a proposed prescription, there's also the PDR•
`Drug Interactions and Side Effects System ™ -
`sophisti(cid:173)
`cated software capable of automatically screening a 20-
`drug regimen for conflicts, then proposing alternatives for
`any problematic medication. This unique decision-making
`tool now comes free with the PDR Electronic Library.
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 003
`
`

`
`For more information on these or any other members of
`the growing family of PDR products, please call, toll-free,
`1-800-232-7379 or fax 201-573-4956.
`
`Physicians' Desk Reference is published by Medical
`Economics Company in cooperation with participating
`manufacturers. Each full-length entry provides you with
`an exact copy of the product's FDA-approved labeling.
`Under the federal Food, Drug and Cosmetics (FD&C) Act,
`a drug approved for marketing may be labeled, promot(cid:173)
`ed, and advertised by the manufacturer for only those
`uses for which the drug's safety and effectiveness have
`-been established. The Code of Federal Regulations
`201.100(d)(1) pertaining to labeling for prescription
`products requires that for PDR content "indications,
`effects, dosages, routes, methods, and frequency and
`duration of administration and any relevant warnings,
`hazards, contraindications, side effects, and precau(cid:173)
`tions" must be "same in language and emphasis" as the
`approved labeling for the products. The Food and Drug
`Administration (FDA) regards the words same in language
`and emphasis as requiring VERBATIM use of the
`approved
`labeling providing
`such
`information.
`Furthermore,
`information that is emphasized
`in the
`approved labeling by the use of type set in a box, or in
`capitals, boldface, or italics, must be given the same
`emphasis in PDR.
`
`The FDA has also recognized that the FD&C Act does not,
`however, limit the manner in which a physician may use
`an approved drug. Once a product has been approved for
`marketing, a physician may choose to prescribe it for
`uses or in treatment regimens or patient populations that
`
`are not included in approved labeling. The FDA also
`observes that accepted medical practice includes drug
`use that is not reflected in approved drug labeling. For
`products that do not have official package circulars, the
`publisher has emphasized the necessity of describing
`such products comprehensively, so that physicians can
`have access to all information essential for intelligent
`and informed decision-making. Particularly in the case of
`over-the-counter dietary supplements, it should be
`remembered that this information has not been evaluat(cid:173)
`ed by the Food and Drug Administration, and that such
`products are not intended to diagnose, treat, cure, or pre(cid:173)
`vent any disease.
`
`The function of the publisher is the compilation, organi(cid:173)
`zation, and distribution of this information. Each product
`description has been prepared by the manufacturer, and
`edited and approved by the manufacturer's medical
`department, medical director, and/or medical consultant.
`In organizing and presenting the material in Physicians'
`Desk Reference, the publisher does not warrant or guar(cid:173)
`antee any of the products described, or perform any inde(cid:173)
`pendent analysis in connection with any of the product
`information contained herein. Physicians' Desk Reference
`does not assume, and expressly disclaims, any obligation
`to obtain and include any information other than that pro(cid:173)
`vided to it by the manufacturer. It should be understood
`that by making this material available, the publisher is
`not advocating the use of any product described herein,
`nor is the publisher responsible for misuse of a product
`due to typographical error. Additional information on any ...._ __
`product may be obtained from the manufacturer.
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 004
`
`

`
`CONTENTS
`
`Manufacturers' Index (White Pages)
`Section 1
`Lists all pharmaceutical manufacturers participating in PHYSICIANS' DESK REFERENCE.
`Includes addresses, phone numbers, and emergency contacts. Shows each manufacturer's
`products and the page number of those described in PDR.
`Brand and Generic Name Index (Pink Pages)
`Section 2
`Gives the page number of each product by brand and generic name.
`Product Category Index (Blue Pages)
`Section 3
`Lists all fully described products by prescribing category. An oveNiew of the headings
`appears on pages 201 and 202.
`Product Identification Guide (Gray Pages)
`Section 4
`Presents full-color, actual-size photos of tablets and capsules, plus pictures of a variety of other
`dosage forms and packages. Arranged alphabetically by manufacturer.
`Product Information (White Pages)
`Section 5
`The main section of the book. Includes entries for over 3,200 pharmaceuticals. Listings are
`arranged alphabetically by manufacturer.
`Diagnostic Product Information
`Section 6
`Gives usage guidelines for a variety of diagnostic agents. Arranged alphabetically by manufacturer.
`
`1
`
`101
`
`201
`
`301
`
`401
`
`3627
`
`Key to Contolled Substances Categorles ............ ...................................................................................... 342
`Gives the definition of each category and the prescribing limitiations that apply.
`Key to FDA Use-In-Pregnancy Ratings ...................................................................................................... 342
`Provides the exact interpretation of each risk/benefit rating.
`Poison Control Centers ............................................................................................................................ 343
`A national directory arranged alphabetically by state and city.
`u.s. Food and Drug Administration Telephone Directory .......................................................................... 3637
`Gives numbers of key reporting programs and information services.
`Adverse Event Report Forms ............................... ................................................................................... 3639
`Contains master copies and instructions for completion.
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 005
`
`

`
`HOW TO USE THE BRAND
`AND GENERIC NAME INDEX
`
`This index lists every product alphabetically by both
`brand and generic name. Generic names are under(cid:173)
`lined; brand names are not.
`
`Under each generic name, you will find a list of the
`brands that contain it. This enables you to find a par(cid:173)
`ticular product by either of its names. For example,
`"Ativan Injection" is listed once alphabetically and
`
`again under its generic name, lorazepam.
`
`Each time a brand name appears, it is followed by the
`manufacturer's name and the page to consult for fur(cid:173)
`ther information. Under a generic heading, all fully
`described brands are listed first, followed by those with
`only partial information. In each case, the brands are
`listed alphabetically.
`
`Brand name
`
`Generic name
`
`Brands of
`lorazepam
`
`Indicates photo
`in Product ldentl-
`fication Guide
`
`ATIVAN INJECTION
`(Wyeth-Ayerst) ................................ 3478
`• ATIVAN TABLETS
`(Wyeth-Ayerst) ....................... 340, 3482
`ATIVAN IN TUBEX
`(Wyeth-Ayerst) ................................. 3606
`
`~
`
`LORAZEPAM
`Ativan Injection
`(Wyeth-Ayerst) ........................ 3478
`Ativan Tablets
`(Wyeth-Ayerst) ................. 340, 3482
`Ativan in 'fubex
`(Wyeth-Ayerst) ........................ 3606
`Lorazepam Intensol (Roxane) ... 3056
`Lorazepam Tablets (Mylan) ...... 2278
`Lorazepam Tablets, USP CIV
`(Watson) .................................. 3369
`• LORCET 10/650 TABLETS
`(Forest) ............................... 313, 1375
`• LORCET PLUS TABLETS
`(Forest) ............................... 312, 1375
`• LORCET-HD CAPSULES
`(Forest) ........................................ 1375
`
`Manufacturer
`
`Bold page number
`Indicates complete
`prescribing Information
`
`Italic page number
`Indicates partial
`prescribing Information
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 006
`
`

`
`SECTION 2
`BRAND AND GENERIC NAME INDEX
`
`This
`index
`includes all entries
`in
`the Product
`Information and Diagnostic Product Information sec(cid:173)
`tions. Products are listed alphabetically by both brand
`and generic name. Generic names are underlined;
`brand names are not. Under each generic name, you
`will find a list of the brands that contain it. This enables
`you to find a product by either of its names. For
`example, the brand Ativan appears once in the A's, and
`again under its generic name, lorazepam.
`Each time a brand name appears, it is followed by the
`manufacturer's name and the page number to consult
`for further information. If multiple page numbers
`appear, the first ones refer to photos of the product, the
`last one to its prescribing information. Under a generic
`
`heading, all fully described brands are listed first,
`followed by those with only partial information.
`• Bold page numbers indicate full prescribing
`information.
`Italic page numbers signify partial information.
`The + symbol marks drugs shown in the Product
`Identification Guide.
`The rm symbol means product information is
`located in PDR For Nonprescription Drugs and
`Dietary Supplements™.
`The 0 symbol means product information
`is located in PDR For Ophthalmic MedicinesrM.
`
`•
`•
`
`•
`
`•
`
`A
`ABACAVTR SUU'ATE
`Triti"'lr l'lb!cLC
`(Gid.wSmuhXImd . .
`z;agm OnJ Soh.1.t1on
`(Gilu ~..WuhKiutl') •••• • ,
`~Tobit
`(Giiu.•< .. thlil""l·...
`ABBO-COOE INDEX IAbboltl
`ABCIXTMAR
`RcoPro Vial< tUlly I.... . .. .
`• ABELCET INJEcnON
`rEIGn/
`AJ<MUIOSF.
`~TAhld,(BayuJ ..•
`• ACCOLATE TABI..£1'S
`fAAtrti.Zf<n«o)
`• ACCUNEB !NliALATJON
`SOL UTION !Dey) ....
`• ACCUPRILTABL.ETS
`(parft.Dot·l~}.
`• ACCURETIC TABLETS
`(Parke Davitt!..
`• ACCUTANE CAPSULES
`rnoa.. La"' "'u.n...1
`•ACClJ'ZYME DEBRIDING
`OINTI>JENr 11/tollhpamll
`319, 1725
`A(;EBUTOJ.,OI. HYDROCHLORIDE
`Sectral Caapr.ul~.- (1\o\t>th·A\u~t) , . 341, 3589
`Accbulolol C:.f""UI~ (Por).
`2609
`Ao:bucotnl H)~ OI["Uic•
`h~h'lultJ.
`
`317, 1669
`
`318, 1692
`
`318, 1692
`• • 402
`
`. . 322, 1958
`
`311, 1273
`
`307.906
`
`305,657
`
`341. 1230
`
`. 330, 2611
`
`• •. 330. 2614
`
`333. 2944
`
`. 2278
`
`-
`
`337, 3249
`
`1154
`
`1907
`321. 1907
`
`309,1070
`
`309. 1070
`
`309, 1070
`
`312, 1317
`3319
`337, 3317
`339, 3399
`3464
`
`339, 3424
`
`J<)dnxhloridc c""'" •
`H~tu~ .,I
`3369
`• ACEl..CllfUNF. 11-'d.er/t)
`320, 185 1
`• ACEON TABLETS (2 MG,
`4 MG, 8 M G) (So/uayl •
`ACES ANTIOXIDANT SOFT
`GELS I(' rl "'I
`A<;E'TAMI!'<OPHEN
`O;u-voro S ;'10 Tabk::~ t Ull.v). •
`lhr\·~ct·N 100 Tahleu (1-AIIVJ
`Exl;l:'lirin Ml~tnunc Coplct"
`(Brl.HIII·Mlt'rs) . • •. • • ••
`Eu:atrm ~t~2lftt OelW:I.
`IBrlstr>l·\h~n) .• . •• • •
`E>:<ednn Mi&rnll< Tol>ku
`(Bnttol·''"'"'· ·••· •••••
`H)'CU!fTUfl(' c,,mpot.md "Tablet.
`(EnJ,, i.l1fU} . •• , , , , •
`, ,
`lorulh Tothlt-liiiUCBJ .•• •••
`Loruh Ehur tVCRJ. _ • •••
`Mu.KP1c rabkh em '"I~U~:•J
`Madrin C'llpAdcl. fMaNtn FmtJ
`Non:o ~'!~ l2hirt, CUI
`(1\iU .... / ...
`Norco 7 .Vl25 l"othlel\ C lll
`(W.lUlil'f}. • ••
`• •
`Nnn:o 1002s T:al'llcu: e m
`
`339,3425
`
`339, 3425
`
`'"U/..,j,, ........ .
`:SCW\;o IOf'~S 'liNoeu em
`,............
`339. 3427
`P=cttt Tobl<h f/'Mo W.J. .
`312, 1326
`Phrenlhd h'f1&:' C.ule"( IAtMOIII
`578
`Phremlln ·nwlelll (A"""nnJ,.,. .
`578
`~p hthleh 50 rn(I/6SO m~ t~l,.r:} 2225
`~.:.~~r,.:.w.,/...
`O.ldm>• Tylenol Sa.pcmlao
`~ and Sofl 0.....
`Chcwabk Tab!«" fMt.X'il
`Cn~rl .
`Cluldrcrt'• l)'h-~•1 AllaJY·fl
`Laljtltod (~1rNf'll Cmu umnJ.
`
`334. 3089
`
`323. 2014
`
`323, 2014
`
`C1ukkm's T)knol Cold
`
`s"""""'"' Liquid lnd
`Che\lo"2ble Tableu. tMcNt!ll
`CIIISumtr) ... ... , .. .. .. .. 323, 2015
`Childtrn') Tykn~ Cold Plus
`c_,,
`~~wr~~~,~~:1and
`Ouldn:r>• T)l<anl Flu
`Suspcnston Laq, ld l~kl\'cil
`Conswnu ).... .. .. .. ..
`Ouldren's TylenoJ Smua
`Su."pensrol'l Liquid f ~kNt'il
`Consumtr/.... .. .... .. .. . 323, 2017
`lntam>' Tylenol c ....... U>~«~
`0n1ps tMrlo"t c-,1-
`,.,.,... • T)knol C<oid
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`Red~ Con«nlrtlt'd l}rop!l;
`(M~Nt>/J Coruumu). 1 • • • • • • • • 323, 2015
`lnfilnl~· l)olcr)Ol Cold
`Occon,csunl and Fc"c.r
`Red..,.,. Con=<r.ao:d Dn>ps
`PIU) Coup (M'"·' ''il
`c ......... ,,
`JuoH>r S<=Jlh T)l- Solt
`Chc-v.-. Ole .... T.attku
`(Mc:Ntil Cc>n.umvr) . .•••• , •
`323, 2014
`rxrn StrenGth "i)'lcool Adult Liquid
`P.1in Rel~"·cr (Md~'t'tl Conmm4"r).
`Exg:1~~·::,t~=
`1.r,-.v~il CnfUIUJVr}. _.. •
`a.,.... Stm!sth '1\lcnol Tablcu
`(Aft:Ndl C.o"u•mrr)... . ..... 323, 2009
`MJ.ximum StrcllJlh 1')-h:-nnl
`Allergy Sinu• C'aJllcu.,
`OciOIP!". and Cclu.,, (AfcN~il
`CMtumt"r)
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`Allerv SUIUI ~tpcTUDC
`Copku (!ol<\'rll ,.,.,_,/.
`l')'lcnol S.•= All<fllY C.ple<s
`(/tfrN~tl ConuunnJ ., • . , • . •
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`Rchd'Caplcb tMcXril
`Ctwn'Wnf'rJ.
`Molti·Symr< ... l')'lcAof Cold
`~F< ........ Capku
`fAf, .\'f'i/ C(llltDIWr}.. . ••
`Mollt4 Symp:om f)"knvl Cold
`~~::::OMi~~~~,~~"=rr}.
`M~~~~~~~:~~:~l Cold
`f'.ion·Orot.\.!\) C".-pku jltf'-\"ril
`c-,1... .. ..
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`~~gh(l'i~ GdatJ"'- t/.lr}.-,.JJ
`c ........ , I.. .. . • .. .. .. .
`Mll.:(in"IUm Slrwsth 'l)llenol Flu
`NlsJliTim< UttUid (AfrNdl
`Consu.fMr} .. _ •• • ,. . • •• • •
`M~~~1-~~~ .. ~d/
`c-" .... .........
`E.otn S=!M Tyl<ool P:\1
`C"!'I<U. G<h""- and Qek:op.
`(/olrt\'f'il CoouurJrr} .,. • • •••. . 323, 2012
`M;mmum S~teni11h l}'knol
`SinUlo Ntgh&'Omt C..apkb
`(Md\ l'd Cwntulft'rl
`o
`\ bumum Ci1rqth l)knol
`Siaaf ~oo-Drowsy Cidbbs.,
`()clap. OIJ>Ictt, and 1'lbku
`W<A<il c.,.,_,,
`\1al>lmum Socn~th l )knot Sort.
`1llrom Aduh l .h1111d rMrN.-il
`c~mumuJ..
`l)rlenol wilh Co«irw 1-]i,tr
`tO,/w> .,,,,.rl/1.
`Tt=.;,~ ~ TohlcU
`~omm·a T)kld \1~
`Relief C:~pku I Me ,,.,.,/
`Cutuumnl ,
`l)'ln'\ D~ul(i (Ortho·Mc-Nt!l/1.
`
`323, 2015
`
`323, 2015
`
`323. 2014
`
`323, 2015
`
`• 2009
`
`323, 2009
`
`323, 2010
`
`323, 2010
`
`. 323, 2010
`
`323, 2009
`
`323, 2010
`
`323, 2010
`
`323, 2011
`
`323, 2011
`
`323. 2011
`
`323. 2011
`
`323, 2012
`
`323, 2012
`
`323. 2013
`
`330. 2595
`330, 2595
`
`323, 2013
`330, 2597
`
`, , • 2763
`
`.. ... 3056
`
`UJ..-101>1«$ (O,,.,.Mr.Vril/.
`• 2597
`. .
`V><odm T>bku (Abl> .. u} .
`.. ..... 304, 516
`VtcOOtn ES Tobit~ (,411/~t~~tJ • ... . . 304, 5 17
`Vicodm IWTablcu (A.bbotl), •••• 304,518
`Zydonc Tobie<> (£nJ.• Lubt/.
`312, 1330
`A.:<Um•rq>hcn ra.-1.. .. . . .
`3613
`~OniS->Iudoa
`(Gftond/ . .... . .... .............. . 3613
`Ac<Um•rq>hcn 0..1 S ~u1"'" USP
`I Phamllk<utkul A.Hr:k: lod f"s) ,
`• •
`Atclom1nophen and Codeine
`l'lll••rhat< Oral SoiUII(Mt USP
`(Pitarmuuldlcal AJ;trJtt'WI('d
`•• • • • •• 2763
`AM.am•oophca and CodciD~o
`f'hoo!olt>r< 0n1 Solwon rR,....,J , •• • 3056
`Ac.~nophen and C'ukt~
`f'l>oo.phl1< ToblcU 1/io""'''· .
`J\telarntnopht:n anti CuJdnc:
`l'hfl'pltDI< Tnbleu. LSP Clll
`. • 3369
`(~~illlOtrl..... ..
`.. •
`Acttlcd Cok.l & Sanu.' Capkt. tpti:rr
`c:a.s--,1.... .. . ... ........... 2760
`-
`JOO ~ lllaAull/ ......... 1025
`AAOC<t c..,.w.. IS.WO:<I .... - .. ... 3094 I
`Bcnadt)·l Allazy &. Stwot~ llc:ar.1.atchc
`Craplet.< & Geltupl (Pj1:rr
`. ••••••• 2761
`{'()lffllrrll'f) •••
`' •• •• •
`Brnac.lryl Allcrg)IC'old fahlch (P/r.Jr
`Ct~tltuuvr,l.. • 4 ...
`• . . . • .. 2760
`8U('IpToi>kurECRI ............ .. .. . l266
`B...UbotAI.A-""'*"-.1
`Qdrbnc Tabkb USf (/tf,rJJ,ftdmdtJ .•• 1992
`llut.albttal, Acctanurq.wn. an.J CaO'a~
`Tahclctl, USP ( " (r1J4M)., •• •• , •••••• 3369
`C'c.ralal ltld Codetllle OnaJ Swopc:nsion
`• .. .. ~·••• · • · •••• • • 577
`(AMf.li'IIIL
`•
`Cod<one~and
`A-..opio<ft Toblrtt. t;SP
`r.•t..tlotf<inodtt . .. . .... .......... 1993 1
`1-...~- Tobleu, USP Cll ll:ndu
`Grnrnrr). • • • • • • , • • •. , ........ . 1316
`·~'&ia; C.apt.Uit$ (f.'lltt'J,j, . •••••• .• • •• 1370
`l.'g~e Ta~k:t.\ (Fnti"JtJ,, . • •
`• •• •••• • , 1370
`l.::ll!I.:·PIUS Tabku (1-"tttrJrJ •• •• • 3J2. 1370
`ll)<inxrt C:..,.W.. lA"''""'•,. .
`, , 577
`11)-..,.,.. 8·--
`~damJnophcn Capuk)
`(Mullmcl..rodO.
`... • .. • .. . • • • .. 1993
`l l)·dn»el"Kklne Bilattr"Att' •n.:t
`At:clnlrunophtn l:.hll';ll
`tM,d/ltt€"kmdtJ.
`,. • • ............. 1994
`tl)dtucodonc: B1llrUatC and
`"-~ltltOphcaEht.al
`tPittlf•Jo't'tltlo.M A•<Jt.adtnJ.
`H)druoooion< 811artn0<1nd
`A'ctAI!ll.nOphen Tablrt' t:SP
`(/ofulltnrtrodt~ •• •. , •.• •• , . .... • • •• • 1994
`I l)'dmcodonc: B11W1mtr and APAP
`Tbhleb, USPClll '""'"1111 •.... ...... 3369
`
`I
`::: ~~=:.:.:::"~ ~;~ ::;~ I
`
`I
`
`""""'"~'.,._. H)«odolondo W
`Accoontn•~ Tab&et..'. USP ('IV
`( UliiJIHt}, ,
`• , .• ,
`. •
`Propo•)·pll<ne H;drochlot><lc and
`Acctanunorflcn Tablets (Mrlun' . . .. 2278
`Propo•)phcnc Sol")'blc and
`......, '"'opb<a Table<> t M..W./ .. ... 2278
`"'->lll>'nci'IP')'III<*
`-...p-..n Tabl&,.I.:SP
`(Mol/udmdlj.....
`• ........ 1997
`Ro:tticxt S/SOO C.plel$ (Ro:vm.-J. . ••• .• 3056
`Ro:d cct Oral Solutl(m (R/Jwm•J. , • , • • •• 3056
`Roxit,:(t Tl&hi&(Romnt').
`, • , _a. , . 3056
`•
`Sinucalt Su ... A1ictJy Mabcatann MS
`c:--,1 .. .. . .. . .. . .. . 2762
`S.nu1ab Stnut Mc:d:icshon \tS Wrthout
`Ort,\l.· .. ane"' .. ~u. aOIJ Capkt~ro
`(l'fi;.tr CfH'I.frunttr) • ,, ••• , • • ,, • • ,. , 2762
`Sudal<d Cold Ill. Cough I •quod C'i"'
`tPfi-:u C•wuw~~er) .... . .. • .. • • •
`Su<lof<d Cold & s,,.,. t.Aquod c.,
`I Pfi;.lr L(M.q,~Wr) • ....... u , . .
`Sudllcd S<>n< CDfd Fonnulll \1S
`Carkb. and Tabl& (PjiJr
`c;,,,..,.,,.,,J, ....•.. I.. , .. , . , , .. 2 762
`Sucbfed Smm. HeAdache Caplei'c and
`l'llbleb (Pji;l'rCon.Jili'U'r} •• , •• • •
`.• 2762
`Zcbut.al c.,....ulel: t Flm l/orl:r11tl. .. •.•• 1359
`ACETA7.01.Al\UDE
`.... T~kt,. CSf' ( T.uol.
`. 3302
`Aa:~
`A«W•< m d< T - USP 111.m. .. 1 ••• 3369
`ACETIC ACID
`Aci·)cl Th.-rnpc:Utac Va,anl.ll Jelly
`(Ort/th.'.f,.\ .<tll ...•
`'A)Sol. HC' OtK SuJulim I ~~.UI
`ACF.TOIIYDROXAl\UC ACrD
`l.atfp II TN
`(MWILiftl
`M<_E'l'YU;YSTF,INE
`Accl)'le;y,.lrtne Sl>ltJiiQn (Rmtmt!J,,I • •
`• 3056
`Mucotn)'~>l fWIII'\'(JJ •
`• .. .. 36J3
`A(;ETYI.'lALICVLIC ACID
`~ u~ ., ASPIRIN)
`ACJ..JEL 'l'BERAPEUTIC
`VAGINAL JELLY rOrtho-\ l eNtil! 2525
`•ACIPHEXTABLETS fEutarl
`311,1267
`• ACIPUEX TABI..£1'S
`!Jan• ·nl
`AC!TRF.TIN
`Sonoo..D<C~(R,odw
`IM .,.. .,. J}
`• ACLOVATE CREAl\! rEianl
`• ACLOVATE OINTMENT
`(E/anl
`ACRlVA!-t'TJNl:
`5<mFn'• D ~ IC<Ut<'CIII
`H.P.ACTIIAR GEL •/ilu.lllrorl
`ACTHIB VACCINE tA• nt1
`Pa"t.-ur) • • • • ••• ,
`ACTt!REL FOR INJECTION
`fF,.. nR),
`•AcnCIN CREAM •&rt•·••
`ACTlDO><E WITH SORBITOL
`SUSPENS ION •Paddnd<J.
`AcnDOSE-AQUA SUSPENSION
`IPadd•dl. .
`.. 2607
`AC'TI.J.'EO COI..D & ALLERGY
`TABLETS (Pfiz~r Con.umrr1
`ACTIFED COLO & SINUS
`CAPLETS fpti..., •r CM.u,.-rr).
`• ACI'IMMUNE llnurAtuntJ
`• ACTIQ IC'rph41orr! .•
`• AC'TIVASE I.V. (C.ntnt«M
`
`Tobltb and c..- rl'ft:.,
`
`3369
`
`2762
`
`2762
`
`2525
`. 3356
`
`j
`
`.. 2233
`
`319, 1783
`
`334. 3003
`311, 1275
`
`311, 1275
`
`1172
`2918
`
`798
`
`1344
`308,998
`
`2607
`
`2760
`
`2760
`319, 1772
`310. 1184
`313, 1410
`
`Descn'bod In POR For Opbfllolaak \1-...,"'
`
`• •
`
`• 2763
`
`lo««-HO C..,.W.. (f""'"'
`1375
`I -2.~ Tlloku f' I"RI... 337. 3319
`I nn••~ 51SOO TDhleh rtrrnJ.
`• .. 337. 3319
`l ""'•b 7~ Tol>I<IIIUC'HI .. .. 337 3319
`l.DfUb 10/SOO T>blm IL'CHI •
`• 337 1319
`
`0't= Us'P~R.::::;~ .. . 3056
`
`0.=~~-n:= 3369
`
`0~~~.~p';f,~/}~~~1:,~, ....... J 996
`0')"1.Tlf.ktne And A(CtaJtUI1•~tl
`r-.._ USPCII tf14tu.,l • ....... 3369
`(h~-.IA<cUnU-.opbcn
`h!oleu. USP 1M..tl•...-bud11 •
`•
`Pmtaznanc: JiCI and Al'!'WltlDD(lhen
`l"a~ku CIV (\\-Uuc"fJ •. ,, ~... • ._.. , , 3369
`rt7R~~ ~.t~ -~odt-':':.7~~:~~~- .1 •• 2929
`
`1996
`
`Roxane Labs., Inc.
`Exhibit 1017
`Page 007
`
`

`
`FF.RROUS GI. UCONATE
`Mc:a~~ TftblcH (A."o'. . . .
`FF.RROUS SULFATF.
`f'co,ol Tat-kt~ {GiaxoSrmthKim~
`CtH1Uirt11'1'}.' . . . 0 • • • • • • • 0 .
`Fcmou• Sull.,. /Cnonol.. ...... .
`F<1'1001~o1ll""'l.>qoid
`rPiw~.-.rnKuJ """"""''· . •••••• 2763
`VdR'tlilliV ADC Va&DIOI + Iron
`o..p Wod\ A-"le!R"'''"
`• • •
`Vi·D.a)hniF \tulb111WU0 + IrOn
`Dn~ With Auoodc: (RlluJ.
`FERTINP.X FOR INJECfiON
`(StrollO}. .
`FF.XOFJ':NADINE
`HYDROC~
`AII•IUJI CBJ"ulc1r (AI'r>lis}..
`Alkp T.Ncu (.A\·r:,tuJ
`•
`
`...,..,..0 Exlmdcd-Rdeasc
`
`112/ETHINYL ESTRADIOL
`339, 3449
`7.-0\'l.l lf\R T.:.~lrt.~ I Ul1/W~1)
`Zo\IIJ 1/.SOt:. ·t~hkt"' l" iJt:um1 •• ••• 339. 3449
`EUtl.~': ~:,:~:cu~~~ .~~1~,
`
`3372
`
`ll•wrA·/h·<nl/. .
`
`3598
`
`2763
`
`.• . •. 865
`
`1409
`
`3372
`
`t " cll\r>r!J
`E'IJUODIZI!D OIL
`Ednod<~ 1•1"·""' rS.• «I- ..... .
`3095
`ETBIOOOL INJECI'ION !S.n'CIIfOI 3095
`E'I1JIONM11DF.
`T,_.,.-S(' Tol>k
`ETUOSUXTMIDF.
`bronlln Ca~uk' (Purk·Da\-u} •• 331 , 2659
`331. 2660
`7.uronun Syrur fPurk~-o~'"''·.
`Elhosullintltk" Syrup tPhtlf'l'fWnu.Jlcul
`,
`.4Hd1Udlll'fl
`£THRANE UQUID FOR
`INBALATION r - r
`Ann.lh~ILJJ.
`IITJIYL.AJ'ITNOBF.N7.0ATE
`"(.;.. untb<" BENZOCAINE!
`ETHYL CKLORIDF.
`Gchouo<'• Ethyl C'hlondc: !Ci<ltowr}.
`ETIIYNODIOL !)!ACETATE
`339. 3449
`Zovia 11:\SF n.hle1~ ( "'imon}.
`7A\'ia 1/~)f. Tnhle1' f"(ttwm). • • 339, 3449
`t:Jb~':, ';:t:~:eu~n;: g:;~r~,
`, ... , .... },
`ETHYOL FOR INJECI'ION
`2029
`IM.&mmu,. OnO>I<>t''l
`ETIDOCAINP.IIYDR~
`• 600
`Durii'IC:Illnj«tkX" IAflroZ.C.ncar UJ.
`~RONATF. DISODIUM
`Otdroncl Tahkh (Pm...·,,. &.
`Gambt .. PlulfmdcC'mlralsJ •••••• 332, 2888
`~DO LAC
`Lodmc Cap\ulo t"'\·tth·AunO ..• 340. 3528
`l.Dcbnc TU,Ictl (\\-\'t'th·A\crst}. • 340, 3528
`Lodm< XI. E•I<Oidod-R<Ia-.:
`Tabid., r'~\..-tlt-Awntl •••• . . . . 340. 3530
`Elodol.oc ~ ood Toblc:u
`
`m.-.,... ... .............
`
`EXTRA STRENGTH PRODUCTS
`(•N bare prOduct nome)
`• 3456
`• ..
`E-Z SPACER IIVd...
`E-Z SPACER AND MASK 111'iol. • .
`3456
`. • •• 3456
`E-Z SPACER MASK 11\<J
`F
`
`. 558
`
`FAC'l'OIU'!!L(,UIF~AIIG)
`AlphanllC Sol\t:nl OtinJt. J/He:~~
`Toaltd IAfrir<'l.
`FA<;'J'O~RUlltAN)
`Moooome Con..:cn1111te {1\\'f.'nth Hrhnnlf) . • 794
`AI~~~~~~~~ ~~~t.~'
`FACTOR IX COMPLF.X
`lkbu!in VH t&l.u~r 1/t'dlllk-.Jh'). . ..
`Koaja< 80 l&nrr s,,.r..
`~J. , • •
`Propk~ TflltJ.MrrHt'dlJit.oJII'I. ~
`Prolilrun< SD Sol- Dct<1J<'II Trar.d
`IAiploJI..
`FACTREL ffi)'<th-~ntll ••
`FAM<;ICLOVJR
`l~llnl\'lf Toblrts (Ntnvu'llfl
`
`558
`
`840
`937
`. 851
`
`558
`3633
`
`2348
`
`320.1814
`
`320. 1814
`
`320, 1814
`
`.. amotidmc ln)CCtion l&rUt'r lr.M.fllw-s•oJ . 866
`~pcid AC Olr"'·-.bk Tal\kt•
`.
`II&J • Mm*l·
`Pq>cid AC Gdapo IJ&J •
`.W~trkJo •• • •• •. o • •• • ••• •
`l'q>o;MIAC Tablet> (J&J •
`Af,.~lc) •••• ••••••••••••
`Pcpad Complcie Cbc,.al>l<
`320. 1815
`fol>l<l> (J&J • "'"""....
`. • 2153
`P.pcrd ln]«llon (Afm·AJ, . •
`• •• 2153
`Pepcid ln,J«tion Pn:mi•td (Mrrt·kl.
`Pcpcld for Onl Suspen.'-iOO tMurl:) • •• 2150
`~~.~~.?,:;'~.,..IMmkJ. 324, 2150
`324, 2150
`P.pnd 'l'ahl<b IAI•~·AJ. ••••
`3613
`. ••
`f ............ (~l -
`2278
`F"""""""' Tobicu IAf>l.»rl.
`2609
`F......SU.. T.t>l<u 1/'ar/ .• ,
`
`Famobdil'll" T.ablttJ t\l:otl *"' .. ..
`
`. 3369
`
`2348
`
`. 335, 3115
`
`• 335. 3115
`
`336, 3237
`.... 843
`
`338,3343
`338.3343
`
`338.3343
`
`338,3343
`
`331, 2685
`
`305, 608
`
`305. 623
`
`312, 1370
`
`3000
`
`PHYSICIANS' DES K REFERENCE®
`FLUDARABINF. PIIOSPRATE
`Aucbn (or lnJ«Iion t 81'rl~., ~ ..... 308, 995
`FLUDROQ.ORTISONF. ACET~
`, 2250
`Aotintf Acetace Tablet' (ftiMdrrhJ. • •
`• . 1370
`FLUMADINP. SYRUP IFor<Jill..
`+ FLUMADINE TABLETS
`IF,..,I
`FLl!MAZY.NtL
`Romanron lnJCC 1M I lttii:N
`LDboruk>Ot"JJ.
`Pl.YNJ'SOLIDF.
`Acrobid lnhAiu S)~tc:m rFmYstJ .. 312, 1363
`Act~id·M lnh:t.lcr S)',lcrn
`( Forr<t(,.. .. . . • • •• • .. .. • 312, 1363
`N .... id< N.,.l Spn<y (t:lwr} • •.•••••• 1295
`• 1296
`N•""<l N•..al Solulion 0.025'7 (lilonl •
`f'!.J,I~INOLONF. ACETONID£
`1400
`ClpeJ< Shompoo (GoiJm•ol. • • • •
`2020
`Synolv c.-. flo/tt/>, u}.
`.. 2020
`SJ=Ial Ou•,.... (MnlimJ ••• • ••
`2020
`S)'lalar TopK:al Soluhon (Mbt..-U,, ••
`1727
`o.:rm.S,._hei!-S T-Il 0.1 IHilll
`FLUOC~ONIDR
`LJ&:.~t C~am (M~dt~uJ. • . • . . • . . • . . 2020
`

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