DOCKETS ENTERED on May 28, 1999

TABLE OF CONTENTS
(ONLY FOR HYBERLINKED ITEMS)

92N-0139 Statement Policy: Foods Derived from New Plant Varieties
97N-0289 Pregnancy Labeling; Content & Format Requirements
98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA
98D-0994 Draft Guidance for Industry on BACPAC I
98N-0583 Exports: Notification and Recordkeeping requirements
98N-1038 Irradiation in the production, processing, &handling of food
98N-1265 Distribution of Compounded Drug Products
98P-0151 Introduction Of Downed Cattle Into The Food Supply
98P-0203 Eliminate Forced Molting of Laying Birds
98P-1194 Withdrawal NADA Approval for Posilac - rBGH
98V-0709 Variance App. for Senographe DMR Mammographic Imaging System
99D-0484 Accelerated approval products/submission promotional materia
99D-0557 Use of Nonhuman Primate Xenografts in Humans
99M-1520 PMA Thermo Cardiosystems Inc, HeartMate VE LVAS P920014/S7
99N-1174 Development of Strategy for Dietary Supplements
99P-1340 Declared Eternity eau de Parfum Misbranded
99P-1653 ANDA for Pamidronate Disodium Injection
99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN
99P-1656 Draft Regulatory Procedures regarding Warning Letters on web
99P-1657 Butalbital,Acetaminophen,& Caffeine tablets/capsules
99P-1658 Codify Existing Practice to determine Active Ingredients
99P-1659 Withdrawal of ANDA for URSO or rename
99V-1655 variance for Mobolazer ML10-250, ML10-300, ML10-300W et al

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78N-0038 Sunscreen Drug Products

BKG 2 Vol#: 129

NFR 1 Vol#: 128

79G-0372 Cellulase enzyme in processing food

NFR 1 HFS-24 Vol#: 1

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92N-0139 Statement Policy: Foods Derived from New Plant Varieties

C 5382 Kathryn Loveland Vol#: 99

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95S-0117 Human Drugs Patent Term Extension & New Patents

LST 43 List as of May 13, 1999 Vol#: 3

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97N-0289 Pregnancy Labeling; Content & Format Requirements

C 4 Rosario Zisa, C. P. A. Vol#: 6

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98D-0266 Section 121 Positron Emission Tomography (PET) FDAMA

C 4 Institute for Clinical PET Vol#: 1

TOP

98D-0994 Draft Guidance for Industry on BACPAC I

C 37 Roche Diagnostics Vol#: 2

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98N-0583 Exports: Notification and Recordkeeping requirements

C 2 Medical Device Manufacturers Association Vol#: 1

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98N-1038 Irradiation in the production, processing, &handling of food

C 2158 Tras Berg Vol#: 52

C 2159 illegible Vol#: 52

C 2160 Nancy Oesau Vol#: 52

C 2161 Janet Taylor Vol#: 52

C 2162 Barbara Mills Vol#: 52

C 2163 Nancy Biglane Vol#: 52

C 2164 Bob Mueller Vol#: 52

C 2165 R. Lancaster Vol#: 52

C 2166 Margaret Kellums Vol#: 52

C 2167 Patricia Carter Vol#: 52

C 2168 Erin Larkin Vol#: 52

C 2169 no signature Vol#: 52

C 2170 Mark Myerson Vol#: 52

C 2171 Margaret Roberts Vol#: 52

C 2172 Sandra Darling Vol#: 52

C 2173 Dave Gott Vol#: 52

C 2174 Rita L. & Howard M. Abens Vol#: 52

C 2175 Barbara D. Musicant, D.C. Vol#: 52

C 2176 Cynthia S. Beach Vol#: 52

C 2177 Bonnie Bator & Family Vol#: 52

C 2178 Nicole Lamphere Vol#: 52

C 2179 Natural & Medicinal Products Research Vol#: 52

C 2180 Morgan Gaddes Vol#: 52

C 2181 Ellen Adams Moore Vol#: 52

C 2182 Gabriel T. Sanchez Vol#: 52

C 2183 Janet Kamiya Vol#: 52

C 2184 Linda Pavlovich Vol#: 52

C 2185 Joy Gurule Vol#: 52

C 2186 Betty Ricks Vol#: 52

C 2187 Cedron Jones Vol#: 52

C 2188 Alice Ruble Vol#: 52

C 2189 Marguerite Kelly Vol#: 52

C 2190 Mary E. Sheehan Vol#: 52

C 2191 Eva Uran Vol#: 52

C 2192 Margaret Gribskov Vol#: 52

C 2193 Clare T. Pelkey, CSJ Vol#: 52

C 2194 Paula Mayer & Dorothy Groteluschen Vol#: 52

C 2195 Marilyn Zilinski Vol#: 52

C 2196 F. E. Brown Vol#: 52

C 2197 Suzanne Daughton Vol#: 52

C 2198 Meg Birdsall Vol#: 52

C 2199 Joe & Mary Zuckerman Vol#: 52

C 2200 Scott W. Campbell Vol#: 52

C 2201 Jennifer A. Birdsall Vol#: 52

C 2202 Mountain Partners in Agriculture Vol#: 52

C 2203 Susan Israilevich Vol#: 52

C 2204 Health Seekers Group Vol#: 52

C 2205 Macon L. (Rusty) Bynum Vol#: 52

C 2206 B. A. Skirha Vol#: 52

C 2207 Lori D. Weber Vol#: 52

C 2208 Phyllis A. Sanchez Vol#: 52

C 2209 Julia M. Hul Vol#: 52

C 2210 Mary Cuchna Vol#: 52

C 2211 Patricia Fields Vol#: 52

C 2212 Jacqueline Gericke Vol#: 52

C 2213 Gorm Lerner Vol#: 52

C 2214 George R. Love Vol#: 52

C 2215 Bryan Mowry Vol#: 52

C 2216 Ray D. Birdsall III Vol#: 52

C 2217 Lorado Adelmann Vol#: 52

C 2218 Jean Binder Vol#: 52

C 2219 Amy Day Vol#: 52

C 2220 Ray D. Birdsall III Vol#: 52

C 2221 Twanette M. Kurle Vol#: 52

C 2222 Daniel Bakal Vol#: 52

C 2223 Mathew Hohmann Vol#: 52

C 2224 Edward H. Zorensky Vol#: 52

C 2225 New Westminster Council of Women Vol#: 52

C 2226 Donna Clearman Vol#: 52

C 2227 Beverly A. Scherling Vol#: 52

C 2228 Carolyn Gunn Vol#: 52

C 2229 Elle & John Guswold Vol#: 52

C 2230 Kresta Carlton Vol#: 52

C 2231 Joel Robbley Vol#: 52

C 2232 David Klingsbeger Vol#: 52

C 2233 Calvin A. Smith Vol#: 52

C 2234 Mr. R. M. Vol#: 52

C 2235 Barry Vinieratos Vol#: 52

C 2236 Rebecca Smith Vol#: 53

C 2237 Elliot Tarabour Vol#: 53

C 2238 Nathan Butz Vol#: 53

C 2239 SUllom Vol#: 53

C 2240 Mike Catalano Vol#: 53

C 2241 Lionel Hasselhoff Vol#: 53

C 2242 Dianne M. Stark Vol#: 53

C 2243 Barbara Harrison, MBA, RD, LD Vol#: 53

C 2244 Terri & Robert Drach Vol#: 53

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98N-1265 Distribution of Compounded Drug Products

C 2695 Ernestine Heywood Vol#: 88

C 2696 Marione Cobb Vol#: 88

C 2697 Ione Dusinberre Vol#: 88

C 2698 Lorene Collins Vol#: 88

C 2699 Doris Giowacki Vol#: 88

C 2700 Healthy Willard Vol#: 88

C 2701 Glenda Thompson Vol#: 88

C 2702 Suzanne Goodelman Vol#: 88

C 2703 Judi Hochman Vol#: 88

C 2704 Carol T. Hauser Vol#: 88

C 2705 Cheryl H. Cohen-Greene Vol#: 88

C 2706 Maryann I. Wortley Vol#: 88

C 2707 Evelyn Marshall Vol#: 88

C 2708 Gail J. Vincent Vol#: 88

C 2709 Ragni Singh Vol#: 88

C 2710 Nicole M. Ray Vol#: 88

C 2711 Maude E. Harmon Vol#: 88

C 2712 Renee Durham Vol#: 88

C 2713 Janice Jones Vol#: 88

C 2714 Cynthia Tarver Vol#: 88

C 2715 Ann Scullion Vol#: 88

C 2716 Elna Rae Zeilinger Vol#: 88

C 2717 Mary Lou Crum Vol#: 88

C 2718 Marsha Tiebert Vol#: 88

C 2719 Karen Liebert Vol#: 107

C 2720 Ursula & Herbert Horejsi Vol#: 107

C 2721 Joanne H. Greenfield Vol#: 107

C 2722 Mickie M. Shea Vol#: 107

C 2723 Joan W. Green Vol#: 107

C 2724 Elaine Bartholomew Vol#: 107

C 2725 Yvonne Van Asten Vol#: 107

C 2726 Anita C. Wilson Vol#: 107

C 2727 Joyce Molloy Vol#: 107

C 2728 Denise Lee Dunlap Vol#: 107

C 2729 Leslie Granson Vol#: 107

C 2730 Shirley Hastings Vol#: 107

C 2731 Helen Luther Vol#: 107

C 2732 Stan & Chris Shroyer Vol#: 107

C 2733 Patricia L. Feum Vol#: 107

C 2734 Leslie Zuber Vol#: 107

C 2735 Linda F. Hunt Vol#: 107

C 2736 Joanne Baier Vol#: 107

C 2737 Felice Underwood Vol#: 107

C 2738 Karen Livington Vol#: 107

C 2739 Merry Stanford Vol#: 107

C 2740 Retha D. Clark Vol#: 107

C 2741 Jeannie Adenbach Vol#: 107

C 2742 Kelly Shackerford Vol#: 107

C 2743 Barbara Shipmans Vol#: 107

C 2744 Dorothy Doyle Vol#: 107

C 2745 Shirley Hastings Vol#: 107

C 2746 Carol Arcand Vol#: 107

C 2747 Warren Hatch Vol#: 107

C 2748 Janice Franchak Vol#: 107

C 2749 April Lorick Vol#: 107

C 2750 Mary Jane Robinson Vol#: 107

C 2751 Sylvia Claffey Vol#: 107

C 2752 R. McCracken Vol#: 107

C 2753 Gladys Cason Vol#: 107

C 2754 Lenora Black Vol#: 107

C 2755 Ivaleen Byrnes Vol#: 107

C 2756 Maria Miyahara Vol#: 107

C 2757 Mari Mennel-Bell Vol#: 107

C 2758 Pamela Paul Vol#: 107

C 2759 Janet Wierzchowski Vol#: 107

C 2760 A. Lori Braun Vol#: 107

C 2761 B. Carroll Vol#: 107

C 2762 Sheryl Spencer Vol#: 107

C 2763 Joan E. Whitwell Vol#: 107

C 2764 Sally Di Paolo Vol#: 107

C 2765 Lee E. Calder Vol#: 107

C 2766 J. H. Sutter Vol#: 107

C 2767 Jenny Burton Vol#: 107

C 2768 Pamela A. Slick Vol#: 107

C 2769 Betty L. Jessup Vol#: 107

C 2770 David P. Bartos Vol#: 107

C 2771 Molly Pardo Vol#: 107

C 2772 Silva DeCarlo Vol#: 107

C 2773 Daniel Pardo Vol#: 107

C 2774 Kathleen A. Kinkel Vol#: 107

C 2775 Ron Kennedy, M. D. Vol#: 107

C 2776 Rosemary T. Miller Vol#: 107

C 2777 Denny Martin Vol#: 107

C 2778 Lee F. Kass Vol#: 107

C 2779 Illegible Vol#: 107

C 2780 Michele Queen Vol#: 107

C 2781 Christine Astopoff Vol#: 107

C 2782 Vincent Turek Vol#: 107

C 2783 Mary-Jane Heitzmann Vol#: 107

C 2784 Valerie Byrne Vol#: 107

C 2785 C. Rae Vol#: 107

C 2786 James A. Albright Vol#: 107

C 2787 Gail W. Johnson Vol#: 107

C 2788 Adriane Elman Vol#: 107

C 2789 Nancy O. Nyberg Vol#: 107

C 2790 Kay M. Landolt Vol#: 107

C 2791 Cornelia G. Cumming Vol#: 107

C 2792 Rhoda Goldberg Vol#: 107

C 2793 Betty Carmichael Vol#: 107

C 2794 Lory J. Maltby Vol#: 107

C 2795 Mary Davis Vol#: 107

C 2796 Marie Goldenberg Vol#: 107

C 2797 Dexter Strawther Vol#: 107

C 2798 Joyce Floherty Vol#: 107

C 2799 Joanne D. Smith Vol#: 107

C 2800 Elizabeth H. Buckley Vol#: 107

C 2801 Larry W. Earley Vol#: 107

C 2802 Carolyn Berrey Vol#: 107

C 2803 Douglas J. Phillips Vol#: 107

C 2804 Patty White Vol#: 107

C 2805 Freeman Robinson Vol#: 107

C 2806 Malchia S. Olshan Vol#: 107

C 2807 Alfonse G. Karacand Vol#: 107

C 2808 Sherrie Woodward Vol#: 107

C 2809 Sarah Warefield Vol#: 107

C 2810 E. Barney Vol#: 107

C 2811 Mr & Mrs Hayden Jameson Vol#: 107

C 2812 Therese Thomas Vol#: 107

C 2813 Terri Gottier Vol#: 107

C 2814 Helen Goodman Vol#: 107

C 2815 Dave Golich Vol#: 107

C 2816 Kathleen Rife Vol#: 107

C 2817 Triple D. Corporation Vol#: 107

C 2818 Lula Wagoner Vol#: 107

C 2819 Deborah J. Thomas Vol#: 107

C 2820 Illegible Vol#: 108

C 2821 R. Waldron Vol#: 108

C 2822 Joanne Molinari Vol#: 108

C 2823 Rebecca H. Bresa Vol#: 108

C 2824 Marcia A. Waldron Vol#: 108

C 2825 Susan Marya Baronoff Vol#: 108

C 2826 Elizabeth Snyder Vol#: 108

C 2827 Jarry Dolby Vol#: 108

C 2828 Sue Dobby Vol#: 108

C 2829 Mary Russell Vol#: 108

C 2830 Lexa Jean Most Vol#: 108

C 2831 Maxine Centala Vol#: 108

C 2832 Marcy Herman Vol#: 108

C 2833 Dynda Post Vol#: 108

C 2834 Evelyn G. Wilson Vol#: 108

C 2835 Allison Leisten Vol#: 108

C 2836 Carolyn Wallen Vol#: 108

C 2837 Russ Kyncl Vol#: 108

C 2838 Sarah K. Yost Vol#: 108

C 2839 Karen Olson Vol#: 108

C 2840 Shari Koelsch Vol#: 108

C 2841 Wanda H. Miller Vol#: 108

C 2842 Adrienne Rosen Vol#: 108

C 2843 Charlotte Fox Vol#: 108

C 2844 Ellen P. Cullman Vol#: 108

C 2845 Kathleen E. Sharp Vol#: 108

C 2846 Margaret P. Hart Vol#: 108

C 2847 Carole A. Merrill Vol#: 108

C 2848 Mercedes Perez Vol#: 108

C 2849 Beverly R. Finigian Vol#: 108

C 2850 Rosemary E. Skow Vol#: 108

C 2851 Rita Vanacore Vol#: 108

C 2852 Marianne Hudzik Vol#: 108

C 2853 Mary C. Covell Vol#: 108

C 2854 Michael Hudson Vol#: 108

C 2855 Cheryl Zuehhdorff Vol#: 108

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98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2201 Sharon M Vance Vol#: 53

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98P-0203 Eliminate Forced Molting of Laying Birds

C 1474 Ms Linda Howell Vol#: 35

C 1475 Cynda Swanson Vol#: 35

C 1476 Maria A Sappe Vol#: 35

C 1477 Wendy Kobylarz Vol#: 35

C 1478 Nancy Gordon Vol#: 35

C 1479 Pauline Berke Vol#: 35

C 1480 Battalldeann Vol#: 35

C 1481 Mrs Eileen Zuehanan Vol#: 35

C 1482 Leah Olsen Vol#: 35

C 1483 Jeanne Schieferstein Vol#: 35

C 1484 Joanne Flynn Vol#: 35

C 1485 Marilyn Mintz Vol#: 35

C 1486 Nancy James Vol#: 35

C 1487 Janet C McQuillen Vol#: 35

C 1488 Kathryn Shaw Vol#: 35

C 1489 Wendy Fodness Vol#: 35

C 1490 Illegible Vol#: 35

C 1491 Sharon M Vance Vol#: 35

C 1492 Arthur Sturm Vol#: 35

C 1493 Mr & Mrs P Caputi Vol#: 35

C 1494 Diane Riel Vol#: 35

C 1495 Michael G Tekel Vol#: 35

C 1496 R Flygar Vol#: 35

C 1497 Susan F Collis Vol#: 35

C 1498 Mrs Dorothy Finger Vol#: 35

C 1499 Jamey Lee West Vol#: 35

C 1500 Jeff & JoElla Mang Vol#: 35

C 1501 Stephen Winsor Vol#: 35

C 1502 Diane McGowan Vol#: 35

C 1503 Kathryn E Riedel Vol#: 35

C 1504 Mr & Mrs Norbert McCaffrey Vol#: 35

C 1505 Ms Jill Hopper Vol#: 35

C 1506 Susan & Hubert van Wyck Vol#: 35

C 1507 Janet L Parrish Vol#: 35

C 1508 Ms June Raskin Vol#: 35

C 1509 Deborah L Valentine Vol#: 35

C 1510 Maryellen McGugan Vol#: 35

C 1511 Barbara Bogner Vol#: 35

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 131 Rebecca Smith Vol#: 3

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98V-0709 Variance App. for Senographe DMR Mammographic Imaging System

SUP 1 General Electric Company Vol#: 1

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99D-0484 Accelerated approval products/submission promotional materia

C 1 Genzyme Tissue Repair Vol#: 1

C 2 PhRMA Vol#: 1

C 3 Merck & Co Inc Vol#: 1

C 4 Wyeth-Ayerst Research Vol#: 1

C 5 Pharmacia & Upjohn Vol#: 1

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99D-0557 Use of Nonhuman Primate Xenografts in Humans

C 10 Nan Vollbracht Vol#: 1

C 11 Mark C Niblack MD Vol#: 1

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99F-1420 Amend to provide safe use of butylated reaction product

NFL 1 Goodyear Tire & Rubber Co Vol#: 1

99F-1422 Amend safe use of antioxidants and/or stabilizers for polyme

NFL 1 Sumitomo Chemical Co Ltd Vol#: 1

99F-1423 Safe use of Slimicide in food-contact Paper and Paperboard

NFL 1 Yoshitomi Fine Chemicals Vol#: 1

99F-1456 Olefin Polymers Intended for Use in Contact with Food

NFL 1 Ciba Speciality Chemicals Corp. Vol#: 1

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99M-1520 PMA Thermo Cardiosystems Inc, HeartMate VE LVAS P920014/S7

AAV 1 Thermo Cardiosystems Inc Vol#: 1

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99N-1174 Development of Strategy for Dietary Supplements

C 3 Amway Corporation Vol#: 1

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99P-1340 Declared Eternity eau de Parfum Misbranded

C 1 Daliya Robson Vol#: 2

C 2 Nancy Michelli Vol#: 2

C 3 Susan Wells Vaughan Vol#: 2

C 4 Nat Coalition for the Chemically Injured Vol#: 2

C 5 Cindy Mutchie Vol#: 2

C 6 Judith DeCarli Vol#: 2

C 7 Ardell Kruithoff Vol#: 2

C 8 Margaret Blair Vol#: 2

C 9 Loretta Vol#: 2

C 10 Christa Garrett RN Vol#: 2

C 11 Diana Jackson Vol#: 2

C 12 Dianna S Dumelle Vol#: 2

C 13 Peggy L Davis Vol#: 2

C 14 Renee Taback Vol#: 2

C 15 Paul J Reimer MS Vol#: 2

C 16 Susan Jannarone Vol#: 2

C 17 Jane Smith Vol#: 2

C 18 Lisabeth Bryon Vol#: 2

C 19 Shay Cardell Vol#: 2

C 20 L M Bruns Vol#: 2

C 21 Leslie Leonelli Vol#: 2

C 22 Rev Thomas LoCascio Vol#: 2

C 23 Susan Myers Vol#: 2

C 24 Maxine Centala Vol#: 2

C 25 Rita J Putnam Vol#: 2

C 26 Karen Chartier Vol#: 2

C 27 Stephanie Russo Vol#: 2

C 28 Lynn M Fairbanks Vol#: 2

C 29 Sara Byk Vol#: 2

C 30 Sue Williams Vol#: 2

C 31 Pamela Marie Weishaupt Vol#: 2

C 32 Helle Kongevang Vol#: 2

C 33 Alfee West Vol#: 2

C 34 Don Paladin Vol#: 2

C 35 Deby Curcio Vol#: 2

C 36 Ingrid Scherrmann Vol#: 2

C 37 Julia Connolly Vol#: 2

C 38 Suzanne Fisher Vol#: 2

C 39 Brent W Burhans Vol#: 2

C 40 Carolyn S Kelley Vol#: 2

C 41 Reid Magney Vol#: 2

C 42 Janine Melrose Vol#: 2

C 43 Betty J Kreeger Vol#: 2

C 44 Hollie Hoffman Vol#: 2

C 45 Melva Smith Vol#: 2

C 46 Patrice Kerr Vol#: 2

C 47 Jan Hawkins Vol#: 2

C 48 Marjo Jrvinen Vol#: 2

C 49 Dr. Douglas G. Riedmiller Vol#: 2

C 50 Donna Haase Vol#: 2

C 51 L. Darnall Vol#: 2

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99P-1653 ANDA for Pamidronate Disodium Injection

ACK 1 HFA-305 Vol#: 1

CP 1 Mitchell G. Clark Vol#: 1

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99P-1654 Stay Effect Date for Approval of ANDA for generic DIPRIVAN

ACK 1 HFA-305 Vol#: 1

PSA 1 Zeneca Inc Vol#: 1

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99P-1656 Draft Regulatory Procedures regarding Warning Letters on web

ACK 1 HFA-305 Vol#: 1

CP 1 McKenna & Cuneo LLP Vol#: 1

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99P-1657 Butalbital,Acetaminophen,& Caffeine tablets/capsules

CP 1 Mikart Inc. Vol#: 1

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99P-1658 Codify Existing Practice to determine Active Ingredients

ACK 1 HFA-305 Vol#: 1

CP 1 National Association of Pharmaceutical Vol#: 1

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99P-1659 Withdrawal of ANDA for URSO or rename

ACK 1 HFA-305 Vol#: 1

CP 1 Novartis Pharmaceutical Corporation Vol#: 1

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99V-1655 variance for Mobolazer ML10-250, ML10-300, ML10-300W et al

ACK 1 HFA-305 Vol#: 1

VAR 1 Dynamite Sound and Light Vol#: 1

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