Updated as of 12:00 pm, May 25, 1999.  The following documents were entered at the Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860 and are hyperlinked to the actual comments/letters/reports as indicated below.
 

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80N-0042 Anticaries Drug Products for OTC Human Use

LET 46 Consumer Healthcare Products Assn Vol#: 31

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

C 5160 George E Milkowski Vol#: 83

C 5161 Gregg Morris Vol#: 83

C 5162 Allen Kugi Vol#: 83

C 5163 Paris Pastries Vol#: 83

C 5164 Mary Lauppe Vol#: 83

C 5165 Michelle Lieberman Vol#: 83

C 5166 Molly Sheehan Vol#: 83

C 5167 Jane Scott Vol#: 83

C 5168 Arthur & Sigrid Kilcullen Vol#: 83

C 5169 Mrs L DeCourcey Vol#: 83

C 5170 Ms Margaret McBride Vol#: 83

C 5171 Janet K Payne Vol#: 83

C 5172 Marion I Kling Vol#: 83

C 5173 P Swan Vol#: 83

C 5174 Rich Yurman Vol#: 83

C 5175 Frances A Oliver Vol#: 83

C 5176 R Passaretti Vol#: 83

C 5177 Mrs Linda Forsberg Vol#: 83

C 5178 Mary S Huhn Vol#: 83

C 5179 Mrs Berrie Collins Vol#: 83

C 5180 Peter Wirth Vol#: 83

C 5181 James Herce Vol#: 83

C 5182 Kay Van Eps Vol#: 83

C 5183 Linda A Fritz Vol#: 83

C 5184 Ellen A Corrie Vol#: 83

C 5185 Sara M Foster Vol#: 83

C 5186 Deborah Gillen Vol#: 83

C 5187 Ms Margot Feuer Vol#: 83

C 5188 Janice L Vitek Vol#: 83

C 5189 Michelle D Schindler Vol#: 83

C 5190 A Johnson Vol#: 83

C 5191 Mr Daniel Nidess Vol#: 83

C 5192 Mack Elder Vol#: 83

C 5193 Gilbert E Nicholls Vol#: 83

C 5194 Theresa Albrecht Vol#: 83

C 5195 Rose Marie Venuto Vol#: 83

C 5196 Michael Hanaper Vol#: 83

C 5197 Ann Heler Vol#: 83

C 5198 Jennifer Mazel Vol#: 83

C 5199 Catherine Tanner Vol#: 83

C 5200 Annette Loziuk Vol#: 83

C 5201 Heather Tausig Vol#: 83

C 5202 Miriam Thomas Vol#: 83

C 5203 Jyoti Osten Vol#: 83

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94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims

C 991 A C Buckner Vol#: 21

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96N-0135 Protein Derived from Ruminants Prohibited in Ruminant Feed

C 1692 Mr & Mrs A. Z. Eiland Vol#: 86

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98D-1168 Industry on ANDA Impurities in Drug Products;

C 7 Bristol-Myers Squibb Vol#: 1

C 8 Baxter Healthcare Corporation Vol#: 1

C 9 Pharmacia & Upjohn Vol#: 1

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98D-1195 Bioanalytical Methods Validation for Human Studies

C 37 MDS Harris Science Advancing Health Vol#: 2

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98E-0319 GenESA (arbutamine hydrochloride); U.S. Patent #5,234,404

LET 3 The Honorable Q. Todd Dickinson (CI) Vol#: 1

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98E-0487 Denavir (Penciclovir) U.S. Patent Extension # 5,075,445

LET 3 The Honorable Bruce Lehman (CI) Vol#: 1

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98E-0611 FEMARA (letrozole) Patent Extension No. 4,978,672

LET 3 The Honorable Q. Todd Dickinson (CI) Vol#: 1

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98E-0842 Patent Extension AGGRASTAT (tirofiban HCL) 5,292,756

LET 3 The Honorable Q. Todd Dickinson (CI) Vol#: 1

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98H-0299 Civil Money Penalties; Craig Hatch, d/b/a Eldon Store

LET 4 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0347 Civil Money Penalties;GNG of Seattle Inc,d/b/a Stop N Shop

LET 3 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0740 Civil Money Penalties;Phar-Mor Inc,d/ba/ Phar-Mor 124

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0742 Civil Money Penalties;United Energy Inc,d/b/a/ Han-Dee Hugo

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0743 Civil Money Penalties;Winn Dixie Raleigh Inc,d/b/a Winn Dixi

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0760 Civil Money Penalties; Blue Sapphire Corp,d/b/a Corner Place

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0761 Civil Money Penalties;Bond Drug Co of IL Inc,d/b/a Walgreens

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0766 Civil Money Penalties;Roshan L Jain,d/b/a U Stop Food Store

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0768 Civil Money Penalties;Pakson Inc,d/b/a Pe Ell Mini Mart

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0769 Civil Money Penalties;Kenneth Pieper, d/b/a Smiley's Liquor

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0771 Civil Money Penalties;Michael Sexton, d/b/a Apache Satandard

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0772 Civil Money Penalties;Speedway Superamerica LLC,d/b/a Speedw

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0774 Civil Money Penalties;The Southland Corp,d/b/a 7-Eleven Stor

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0775 Civil Money Penalties;Ultramar Diamond Shamrock.d/b/a Stop N

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0827 Civil Money Penalties; All In One Inc.

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0828 Civil Money Penalties;Eckerd Corp,d/b/a Eckerd Drug Store 74

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0872 Civil Money Penalty: Willie Buckley Jr d/b/a Handi Foods

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0874 Civil Money Penalty; Sinclair Oil Corp d/b/a/ Sinclair Produ

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0875 Civil Money Penalty; Ultramar Diamond Shamrock Corp d/b/a St

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

98H-0881 Civil Money Penalty; Chet's Cigar Store, Inc

LET 2 Office of tobacco Programs Vol#: 1

SET 1 GCF-1 Vol#: 1

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98N-0044 Effect of dietary supplement on structure/function of body

C 22308 Ron Gafford Vol#: 771

C 22309 Linda Lee Poland Vol#: 771

C 22310 M. Angelo Vega Vol#: 771

C 22311 Lawrence Darmstedter Vol#: 771

C 22312 Dave Casale Vol#: 771

C 22313 Oscar Estevez Vol#: 771

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98N-0148 Isomers of Psychotropic substances: three drug substances

TS 2 June 1998 Scientific & Medical Expert Vol#: 9 - Video Tape

98N-0182 Bulk Drug Substances To Be Used in Pharmacy Compounding;

C 127 Bernadette F. Mauro Vol#: 19

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98N-0583 Exports: Notification and Recordkeeping requirements

EXT 1 Pharm Res & Manufacturers of America Vol#: 1

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

C 1016 Riess Jackson Vol#: 23

C 1017 John Ebsen Vol#: 23

C 1018 Dave Bruce Vol#: 23

C 1019 Claire Lipsman Vol#: 23

C 1020 Dave Bruce Vol#: 23

C 1021 Jay Kloss Vol#: 23

C 1022 Prophet Vol#: 23

C 1023 Blueberry Software Vol#: 23

C 1024 Sabine Gross Vol#: 23

C 1025 Jeffrey LaNuez Vol#: 23

C 1026 Frank Tomeo Vol#: 23

C 1027 Diana Bowman Vol#: 23

EXT 1 Public Citzen Health Research Grp. Vol#: 23

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98N-1265 Distribution of Compounded Drug Products

C 1708 Sarah D'Amore Vol#: 74

C 1709 Linda J. Taylor Vol#: 74

C 1710 Dorothy DeBoer Vol#: 74

C 1711 Carmen Cieslar Vol#: 74

C 1712 Melba L. Pinotti Vol#: 74

C 1713 Kathryn B. Landis Vol#: 74

C 1714 Kathleen A. Buicato Vol#: 74

C 1715 Anita Hoffman Vol#: 74

C 1716 Georgianne Bohmann Vol#: 74

C 1717 Alana Sugar Vol#: 74

C 1718 Patricia Robinson Vol#: 74

C 1719 Charlotte Ginns Vol#: 74

C 1720 C Nowlin Vol#: 74

C 1721 Jane Smith Vol#: 74

C 1722 Carole Brigham Vol#: 74

C 1723 Jacqueline Warren Vol#: 74

C 1724 Joyce Baker Vol#: 74

C 1725 Julaine Baron Vol#: 74

C 1726 Maurisa Solomon Vol#: 74

C 1727 K. Estes Vol#: 74

C 1728 Cynthia C. Wilson Vol#: 74

C 1729 Sandy Lee Akins Vol#: 74

C 1730 Pam Jackson Vol#: 74

C 1731 Patsy R. Lemanowicz Vol#: 74

C 1732 Laren Couillard Vol#: 74

C 1733 Jacqueline Betermead Vol#: 74

C 1734 Donald W. Stewart Vol#: 74

C 1735 Gail P. Jones Vol#: 74

C 1736 Grace O. McDonald Vol#: 74

C 1737 Florence Laloecyue Vol#: 74

C 1738 Carol L. Rosenzweig Vol#: 74

C 1739 Rose Barney Vol#: 74

C 1740 Claire M. Rideout Vol#: 74

C 1741 Carrol Anderson Vol#: 74

C 1742 Mildred R. Koenigsberg Vol#: 74

C 1743 Susan A. Balog Vol#: 74

C 1744 Suzanne Bixby Vol#: 74

C 1745 Nancy Summers Vol#: 74

C 1746 A. Artemis Vol#: 74

C 1747 Evelyn J. Aurand Vol#: 74

C 1748 Albert L. Clark Vol#: 74

C 1749 Victoria R. Clark Vol#: 74

C 1750 Kathryn Inman Vol#: 74

C 1751 Jeanne McElvaney Vol#: 74

C 1752 Joyce A. Gill Vol#: 74

C 1753 Brenda Terell Vol#: 74

C 1754 Janice M. Hogan Vol#: 74

C 1755 James Ponce Vol#: 74

C 1756 Joanna M. Sherman Vol#: 74

C 1757 Kay Kertis Vol#: 74

C 1758 Mary Alice Lausell Vol#: 74

C 1759 Louise Mellon Vol#: 74

C 1760 Sandra L. Ruff Vol#: 74

C 1761 Alice Ruff Vol#: 74

C 1762 Muriel A. Hardy Vol#: 74

C 1763 Jane Kimbrough Vol#: 74

C 1764 Michelle Billadeau Vol#: 74

C 1765 Judith A. Valenti Vol#: 74

C 1766 Deborah Miserez Vol#: 74

C 1767 Marilyn Kirkland Vol#: 74

C 1768 AFStephens & Association Vol#: 74

C 1769 Linda Kindelspire Vol#: 74

C 1770 Judith Anderson Vol#: 74

C 1771 Linda Sayer Vol#: 74

C 1772 Diane Marino Vol#: 74

C 1773 Phyllis Carozzo Vol#: 74

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

C 2139 Karen A. Thomas Goto Vol#: 52

C 2140 Amanda Higdon Vol#: 52

C 2141 No Signature Vol#: 52

C 2142 Kirk Blaisdell Vol#: 52

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98P-0504 Raw Molluscan Shellfish of Undetectable Levels

C 243 PEI Oyster Co. (Canada) Vol#: 18

C 244 Rhode Island Hospitality & Tourism Assn. Vol#: 18

C 245 freds Central SFD, Inc. Vol#: 18

C 246 Coalition for Consumer Choice Vol#: 18

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98P-0968 Guidance regarding Surimi Ingredient Labeling

C 2 Oregon State University Seafood Laborato Vol#: 1

C 3 AVRI Companies, Inc Vol#: 1

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98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 93 Heather Tausig Vol#: 3

C 94 Miriam Thomas Vol#: 3

C 95 Jyoti Osten Vol#: 3

C 96 Wendy Saunders Vol#: 3

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99H-1175 Civil Money Penalties;Wal-Mart Stores Inc,d/b/a Wal-Mart 295

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1176 Civil Money Penalties; CVS Revco D S Inc,d/b/a CVS Pharmacy

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1177 Civil Money Penalties;Ingles Markets Inc,d/b/a Ingles #33

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1178 Civil Money Penalties;Rice Oil Co Inc,d/b/a West St Texaco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1179 Civil Money Penalties;Warner Ent Inc,d/b/a Alstead Village

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1180 Civil Money Penalties;Grand Union Co,d/b/a Grand Union #1938

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1181 Civil Money Penalties;Peterborough Oil Co Inc,d/b/a Mr Mike'

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1182 Civil Money Penalties;Corborn's Inc,d/b/a Cash Wise

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1183 Civil Money Penalties;Town & Country Supermarket of Mountain

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1184 Civil Money Penalties;Salama Market 5 Inc,d/b/a Salama Super

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1185 Civil Money Penalties;Krakow Store Inc,d/b/a Krakow Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1186 Civil Money Penalties;Richmond Hills United Super Inc,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1187 Civil Money Penalties;Salem Wholesale Beverage Inc,d/b/a Sal

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1188 Civil Money Penalties;Samram Inc,d/b/a Family Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1189 Civil Money Penalties;Twocan Ent Inc,d/b/a Normandy Amoco

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1190 Civil Money Penalties;Gas Unlimited Inc,d/b/a Gas Unlimited

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1191 Civil Money Penalties;Romeoville Amoco Inc,d.b.a Amoco Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1192 Civil Money Penalties;Pak Associates Inc,d/ba/ Amoco Food &

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1193 Civil Money Penalties;Charles Lang,d/b/a Lang's Standard Ser

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1194 Civil Money Penalties;Larry Bunch,d/b/a Galena Country Corne

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1195 Civil Money Penalties;Roby Edwards,d/b/a Phillips Kwik Stop

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1196 Civil Money Penalties;Paul L Wakefield,d/b/a Otis Place

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1197 Civil Money Penalties;Saker Shaath,d/b/a Towne Discount Food

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1198 Civil Money Penalties;Noel Nava,d/b/a C Street Market

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1199 Civil Money Penalties;Hollis Sturdy,d/b/a Circle S Gas & Foo

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1200 Civil Money Penalties;Bilal Hammad,d/b/a Burdget Market Liqu

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1201 Civil Money Penalties;Doha M Fayad,d/b/a Sam's 98 Cent Store

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1202 Civil Money Penalties;Ron Cloer & Debra Cloer,d/b/a Cloer's

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1203 Civil Money Penalties; Manar Razooki & Mundhir Razooki,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

99H-1204 Civil Money Penalties; Markram Hanna & Maureen Hanna,d/b/a

LET 1 Office of Tobacco Programs (HF-11) Vol#: 1

NPH 1 HHS/FDA/CDER Vol#: 1

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99N-0438 Contamination ready-to-eat foods associated food prepartion

RPT 1 Bioscience Laboratories Inc Vol#: 2

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99P-0033 Combat the spread of transmissible spongiform encephalopathy

C 56 Sheree Pottier Vol#: 1

C 57 Joyce Janicki Vol#: 1

C 58 Angela Magnano Vol#: 1

C 59 Natalie Baldwin Vol#: 1

C 60 Celia Newman Vol#: 1

C 61 Robin L. Vol#: 1

C 62 F. C. English Vol#: 1

C 63 Joan M. Weichmann Vol#: 1

C 64 Eunice Feininger Vol#: 1

C 65 J. L. Denison Vol#: 1

C 66 Donald Wright Vol#: 1

C 67 Kristen Buccella Vol#: 1

C 68 Jan Kramer Vol#: 1

C 69 June Anna-Fey Vol#: 1

C 70 Zella Imbregno Vol#: 1

C 71 Naomi Caplan Vol#: 1

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99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 115 Debbie Sharp Vol#: 2

C 116 Mr & Mrs S C Strand Vol#: 2

C 117 Alice Megella Vol#: 2

C 118 George M Mazie Vol#:

C 119 Marilyn B Meyers Vol#: 2

C 120 Ms Fay Graning Vol#: 2

C 121 E Gingerich Vol#: 2

C 122 Ericka De Pasquali Vol#: 2

C 123 Carol Wheeler Vol#: 2

C 124 Mrs Dorothy Finger Vol#: 2

C 125 Carol K Barron Vol#: 2

C 126 Mrs Helen D Brown Vol#: 2

C 127 Nazen Merjian Vol#: 2

C 128 Elisabeth W Gambill Vol#: 2

C 129 Eleanor McIntosh Vol#: 2

C 130 Joseph Brinkmann Vol#: 2

C 131 Lillian R Finnell Vol#: 2

C 132 Florence M Schneider Vol#: 2

C 133 Arnold Meltzer Vol#: 2

C 134 Delores Story Kaufmann Vol#: 2

C 135 Joseph Rodgers Vol#: 2

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99P-1267 ANDA Suitability for Clozapine tablets 12.5mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

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99P-1268 ANDA Suitability for Clozapine Tablets, 200mg

ACK 1 HFA-305 Vol#: 1

CP 1 Lachman Consultant Services, Inc. Vol#: 1

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99P-1271 Stay of Action Regarding Approval of Cisplatin Injection

ACK 1 HFA-305 Vol#: 1

PSA 1 American Pharmaceutical Partners, Inc. Vol#: 1

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99V-1272 Laser Light Show(Omniscan Laser Projection System Model 2000

ACK 1 HFA-305 Vol#: 1

VAR 1 The Renaissance Center Vol#: 1

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