Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870  [E-mail] 

DOCKETS ENTERED on April 6, 2000

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]  [ ITEM CODES ]

 
78N-0070 Combo Drugs Contain Theophylline, Ephedrine & Hydroxyzine *
88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE *
93N-0462 Debarment of Abu Quamruzzaman *
94P-0036 Req labeling of trans fatty acid & prohibit deceptive claims *
96N-0277 Eligibility Criteria for Considering Additional Condition *
96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs *
97P-0360 Expiration Date Labeling of Food Products *
97P-0373 Biological products are also drugs requiring PHSA & FFDCA *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
98P-1194 Withdrawal NADA Approval for Posilac - rBGH *
99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma *
99D-4809 Applications Covered by Section 505(b)(2) *
99D-5046 Human Blood & Blood Components Intended for Transfusion *
99D-5435 Draft Guidance for Industry on Photosafety Testing *
99N-0035 Medical Devices; Reclassification of 38 Preamendments *
99N-4491 Reuse of Single Use Devices proposal *
99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif *
99P-0389 Abbreviated new drug application/topical dematological drug *
99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock *
99P-0795 Amend regulations on bottled water *
99P-1418 Methylphenidate Hydrochloride Chewable Tablets, 2.5mg*
99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast *
99P-2733 ANADA for Ketanil 200 (Ketamine Hydrochloride Inj.*
99P-2852 Condoms Packaging for both latex and non-latex condoms*
99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol*
99P-4209 Hydrocodone Bitartrate & Acetaminophen Tablets*
99P-4932 ANDA Suitability Petitions for Parenteral Drugs *
99P-5105 ANDA for oxycodone hydrochloride, oxycodone terephthalate*
99P-5317 Stay of Approval of ANDA for a Generic Version of Enalapril*
99P-5330 ANADA for enalapril maleate tablets*
00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization*
00D-0087 IND meetings for human drugs/biologics,chemistry,mfging*
00N-0504 Egg Safety Action Plan*
00P-0444 ANADA Suitability for spectinomycin sterile solution*
00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes *
00P-0585 Prozac (Fluoxetine) Tablets Voluntarily Withdrawn *

78N-0070 Combo Drugs Contain Theophylline, Ephedrine & Hydroxyzine

C 3 Karen Laverty Vol#: 68

88N-0258 PRESCRIPTION DRUG MARKETING ACT OF 1987 GUIDELINE

THESE LINKED COMMENTS DUPLICATE THOSE FOR 92N-0297, ALSO BELOW

ACK 2 HFA-305 Vol#: 2

PSA 1 Pharmaceutical Distributors Association Vol#: 2

92N-0297 Prescription Drug Marketing Act of 1987, Drug Amds of 1992

ACK 2 HFA-305 Vol#: 3

PSA 1 Pharmaceutical Distributors Association Vol#: 3

93N-0462 Debarment of Abu Quamruzzaman

C 2 Abu Quamruzzaman Vol#: 1

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

C 2071 Erwady Gunawan Vol#: 57

C 2072 Agnes E. Bjornstad Vol#: 57

C 2073 Clifford M. Winger Vol#: 57

C 2074 Departemen Kehutanan Dan Perkebunan Vol#: 57

C 2075 Kemajuan Agro Pratiwi Korporasi Vol#: 57

C 2076 American Peanut Council Vol#: 57

C 2077 Richard J. Smith Vol#: 57

C 2078 Celeste Jarmow Vol#: 57

C 2079 Frances Willis Vol#: 58

EC 1 Ms. Joy Metcalf Vol#: 311

EMC 471 Estate Crops Vol#: 57

95P-0345 ANDA for dextromethorphan hydrobromide & tripelennamine hydr

WDL 1 HFD-615 to Bock Pharmacal Company Vol#: 1

95P-0351 ANDA Suit for 1 mg Azatadine Maleate & 30 mg Phenylephrine H

WDL 1 HFD-615 to Bocl Pharmacal Company Vol#: 1

96N-0277 Eligibility Criteria for Considering Additional Condition

C 27 BlueCross BlueShield Association Vol#: 3

C 28 Procter & Gamble Vol#: 3

C 29 European Cosmetic Toiletry & Perfumery A Vol#: 3

96P-0418 Reduce the Precense of Salmonella Enteritidis in Shell Eggs

THESE LINKED COMMENTS DUPLICATE THOSE FOR 97P-0197 AND 98N-1230, ALSO BELOW

C 817 Donna Brigham Vol#: 31

97P-0197 Require that warning labels about risks of salmonella enteri

C 818 Donna Brigham Vol#: 30

97P-0360 Expiration Date Labeling of Food Products

C 2 Sue Z. Meyerson Vol#: 1

97P-0373 Biological products are also drugs requiring PHSA & FFDCA

LET 2 Department of Health & Human Services Vol#: 1

98N-1230 Labeling of Shell Eggs;Shell Eggs: Refrigeration of Shell

C 817 Donna Brigham Vol#: 32

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

C 2307 Mrs. Jim Sale Vol#: 291

98P-1194 Withdrawal NADA Approval for Posilac - rBGH

C 775 University of Illinois at Chicago Vol#: 24

99D-4577 Statutory Authority to Nucleic Acid Testing of Pooled Plasma

EMC 1 The Plasma Protein Therapeutics Assoc. Vol#: 1

99D-4809 Applications Covered by Section 505(b)(2)

C 7 PhRMA Vol#: 1

99D-5046 Human Blood & Blood Components Intended for Transfusion

C 2 Coalition for Blood Safety Vol#: 1

99D-5435 Draft Guidance for Industry on Photosafety Testing

C 4 BioSkin Vol#: 1

99H-0906 Civil Money Penalty;Sunny Poma d/b/a Fireside Mini Mart & Li

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

99N-0035 Medical Devices; Reclassification of 38 Preamendments

EXT 3 BIO-REG Vol#: 1

99N-4282 Biotechnology in the Year 2000 and Beyond; Public Meetings

C 5515 JoAnn & Mike Brand Vol#: 299

C 5516 Lois Day Vol#: 299

C 5517 Susan V. Bailey Vol#: 299

C 5518 Emily Earhart Vol#: 299

C 5519 Janet L. Smith Vol#: 299

C 5520 David Chapman Vol#: 299

C 5521 Billy G. Kinneer Vol#: 299

C 5522 Brandi Carter Vol#: 299

C 5523 Robert A. Floyd Vol#: 300

C 5524 Alison Miller Vol#: 300

C 5525 Christy L. Flower Vol#: 300

C 5526 Susan Taylor Vol#: 300

C 5527 Judith Cieslak & Jean Prebis Vol#: 300

C 5528 Brian J. Roy Vol#: 300

C 5529 Kathy Young Vol#: 300

C 5530 Evelyn M. Hellinger Vol#: 300

C 5531 Hanne & Don Madsen Vol#: 300

C 5532 Robinette Garrison Vol#: 300

C 5533 Wendy Lessard Vol#: 300

C 5534 Laura Townsend Vol#: 300

C 5535 Sue Thiemann Vol#: 300

C 5536 Rena Daniel Vol#: 300

C 5537 Carolyn Doyscher Vol#: 300

C 5538 Margaret Tenney Vol#: 300

C 5539 Phil Schmidt Vol#: 300

C 5540 Margaret Cayea Vol#: 300

C 5541 Maxine B. Jarrell Vol#: 300

C 5542 Harold Rose Vol#: 300

C 5543 Cath Stewart Vol#: 300

C 5544 Fred Neurohr Vol#: 300

C 5545 Barbara Rokas Vol#: 300

C 5546 Marjorie Magnusson Vol#: 300

C 5547 Beth Vail Vol#: 300

C 5548 Darlene A. Krecht Vol#: 300

C 5549 Harrison B. Metz Vol#: 300

C 5550 Patricia Shawley Vol#: 300

C 5551 Helen M. Pavlich Vol#: 300

C 5552 Judith Turner Vol#: 300

C 5553 Theodore R. Buisker Vol#: 300

C 5554 Joan B. Rathbone Vol#: 300

C 5555 Kathleen J. Serafin Vol#: 300

C 5556 Jessica Offir Vol#: 300

C 5557 Kathryn Lohrey Vol#: 300

C 5558 Maureen R. Johnston Vol#: 300

C 5559 Lloyd B. Stauffer Vol#: 300

C 5560 Valerie Dambacher Vol#: 300

C 5561 Sophey Thain Vol#: 300

C 5562 Donna Middlebrook Vol#: 300

C 5563 Meg R. Hanrahan Vol#: 300

C 5564 Kate Stevens Vol#: 300

C 5565 Martin J. Kotowski Vol#: 300

C 5566 Patrick Caporal Vol#: 300

C 5567 Loretta L. Ellery Vol#: 300

C 5568 Ron Hornback Vol#: 300

C 5569 Martha Kobs Hays Vol#: 300

C 5570 N.J. Leonard Vol#: 300

C 5571 Baveara Sean Vol#: 300

C 5572 Kimberly Aichele Vol#: 300

C 5573 Barbara J. Gogan Vol#: 300

C 5574 Dorothy A. Sessler Vol#: 300

C 5575 Alma Gehman Vol#: 300

C 5576 Bill Szuch Vol#: 300

C 5577 Susanne Hodgson Vol#: 300

C 5578 Carol Hambrecht Vol#: 300

C 5579 Steven J.A. Shook Vol#: 300

C 5580 Toni Kruger Vol#: 300

C 5581 Dorothy Bidmar Vol#: 300

C 5582 Chloe Barrett Vol#: 300

C 5583 Chris David Vol#: 300

C 5584 Albert J. Weldon Vol#: 300

C 5585 Karen Fiscus Vol#: 300

C 5586 Robert A. Parma Vol#: 300

C 5587 Barbara Byrd Vol#: 300

C 5588 Samuel & Deborah Lind Vol#: 300

C 5589 Isabel Allen Vol#: 300

C 5590 Valerie Yates Vol#: 300

C 5591 Ron & Voncille Henry Vol#: 300

C 5592 Linda West Vol#: 300

C 5593 Kim Meadows Vol#: 300

C 5594 Carolyn M. Hackel Vol#: 300

C 5595 Janet W. Lowe Vol#: 300

C 5596 Penny Will Vol#: 300

C 5597 Joel & Cindi Armistead Vol#: 300

C 5598 Allan D. Rammer Vol#: 300

C 5599 Jan Montgomery Vol#: 300

C 5600 Marty Balogh Vol#: 300

C 5601 Sherry M. Easton Vol#: 300

C 5602 Corie Austin Vol#: 300

C 5603 Shirley Arlene Bartlett Vol#: 300

C 5604 Lisa S. Tennant Vol#: 300

C 5605 Frances Isabele Hartwell Vol#: 300

C 5606 Frank W. Heathermaton Vol#: 300

C 5607 John Robert Eeles Vol#: 300

C 5608 David Triggs Vol#: 300

C 5609 Carol A. Peterson Vol#: 300

C 5610 Eleanor E. Cone Vol#: 300

C 5611 John M. McNeill Vol#: 300

C 5612 Eric Hambilton Vol#: 300

C 5613 Barbara Ellen Olson Vol#: 300

C 5614 Ellen Pauly Vol#: 300

C 5615 Steven D. Hudson Vol#: 300

C 5616 Beverly Hofmann Vol#: 300

C 5617 Michael A. Wilsey Vol#: 300

C 5618 Wendi Carlson Vol#: 300

C 5619 Richard A. Montgomery Vol#: 300

C 5620 Barbara Stumpp Vol#: 300

C 5621 Dale B. Duff Vol#: 300

C 5622 Floyd P. Blair Vol#: 300

C 5623 Alice Rogers Vol#: 300

C 5624 Violn Oestin Vol#: 300

C 5625 J. P. Gagnon Vol#: 300

C 5626 Lynn Maralister Vol#: 300

C 5627 Tracey Labbe Renault Vol#: 300

C 5628 William S. Heath Vol#: 300

C 5629 John Kellogg Vol#: 300

C 5630 Annette M. Orlos Vol#: 300

C 5631 Sterling Lee Few Vol#: 300

C 5632 Stephen D. Hampton Vol#: 300

C 5633 Patricia Zulkosky Vol#: 300

C 5634 John M. Tindell Vol#: 300

C 5635 Julie E. Mitchell Vol#: 300

C 5636 Mr & Mrs William L. Bulla, Jr. Vol#: 300

C 5637 Ann Marie Doria Vol#: 300

C 5638 Anne Marshalek Vol#: 300

C 5639 Robert Lander Vol#: 300

C 5640 Ann Veltri Vol#: 300

C 5641 C. Miller Vol#: 300

C 5642 Ron Peltoia Vol#: 300

C 5643 Arthur M. Beverly, Sr. Vol#: 300

C 5644 Ann H. Savage Vol#: 301

C 5645 Bradford L. Gleim Vol#: 301

C 5646 Shirley R. Gellis Vol#: 301

C 5647 Carl Rosenstein Vol#: 301

C 5648 John E. Peck Vol#: 301

C 5649 Thomas M. Barrick Vol#: 301

C 5650 Betsy Lincicome Vol#: 301

C 5651 Ruth Niswander Vol#: 301

C 5652 Mike Wyatt Vol#: 301

C 5653 Richard R. Hogue Vol#: 301

C 5654 Deborah Levine Vol#: 301

C 5655 Rebecca Stracener Vol#: 301

C 5657 Natalie Strazzera Vol#: 301

C 5658 Roy Smith Vol#: 301

C 5659 Maria Lipps Vol#: 301

C 5660 Paul A. Feder Vol#: 301

C 5661 Debbie Cox Vol#: 301

C 5662 Marian Wright Vol#: 301

C 5663 Ernest Goitein Vol#: 301

C 5664 Patricia Sims Vol#: 301

C 5665 Geoff Ruth Vol#: 301

C 5666 Joyce Cadoo Vol#: 301

C 5667 Earl G. Jackson Vol#: 301

C 5668 Candy Cureton Vol#: 301

C 5669 Wes Smuder Vol#: 301

C 5670 Paul P. Schachel Vol#: 301

C 5671 Nancy Emerson Vol#: 301

C 5672 Charles R. Venticinque Vol#: 301

C 5673 Anthony Cutroneo Vol#: 301

C 5674 Charlie Wilken Vol#: 301

C 5675 Karen Newmann Vol#: 301

C 5676 Joe Baggette Vol#: 301

C 5677 Philip Wilson Vol#: 301

C 5678 Lynn Hillis Vol#: 301

C 5679 Jon Roberts Vol#: 301

C 5680 Alicia Nenso Vol#: 301

C 5681 Lynn Dunn Vol#: 301

C 5682 Luke Harger Vol#: 301

C 5683 Steve McKim Vol#: 301

C 5684 Noreen A. McCluskey Vol#: 301

C 5685 Shayne Sledge Vol#: 301

C 5686 Mary F. Church Vol#: 301

C 5687 Gwen Fener Vol#: 301

C 5688 Clarence Betty Vol#: 301

C 5689 Audrey A. Davidson Vol#: 301

C 5690 Ruth M. Asaff Vol#: 301

C 5691 Mr & Mrs J. M. Gerstley Vol#: 301

C 5692 Kevin H. Breithardt Vol#: 301

C 5693 R. Vaicus Vol#: 301

C 5694 Glenn Marshall Vol#: 301

C 5695 Sue Aurelia Vol#: 301

C 5696 D. Lynch Vol#: 301

C 5697 Marsha Holzwarth Vol#: 301

C 5698 Jeanine A. Bothun Vol#: 301

C 5699 Healy Hermone Vol#: 301

C 5700 Roberta Bright Vol#: 301

C 5701 Garrott Stewart Vol#: 301

C 5702 Erna Bethre Vol#: 301

C 5703 Bruce J. Bishoff Vol#: 301

C 5704 Janine Jones Vol#: 301

C 5705 James R. Van Horn Vol#: 301

C 5706 Carol Logan & Eugene Tindal Vol#: 301

C 5707 Ray A. Purifog Vol#: 301

C 5708 Mr & Mrs James Larson Vol#: 301

C 5709 Catherine L. Jacobs Vol#: 301

C 5710 Round Up Ready Plant Vol#: 301

C 5711 Roger & Sadie Lessenger Vol#: 301

C 5712 Leota Parker Vol#: 301

C 5713 M. Lucille Wright Vol#: 301

C 5714 Sue Kaufman Vol#: 301

C 5715 Roberta Plummer Vol#: 301

C 5716 Harold J. Kovacic Vol#: 301

C 5717 Alice E. Marini Vol#: 301

C 5718 Linda Werner Vol#: 301

C 5719 Mr & Mrs Clare J. Seaman Vol#: 301

C 5720 Mark & Naomi Dambacher Vol#: 301

C 5721 Edward E. Fein Vol#: 301

C 5722 Jerry K. Bird Vol#: 301

C 5723 Mr & Mrs L. M. Yeutter Vol#: 301

C 5724 Wanda W. Reese Vol#: 301

C 5725 Jana L. Call Vol#: 301

C 5726 Betty Lindgren Vol#: 301

C 5727 Charles Kraus Vol#: 301

C 5728 Nita G. Weinstein Vol#: 301

C 5729 Rebecca Spoon Vol#: 301

C 5730 Grave & Deborah Trail Vol#: 301

C 5731 Richard Kover Vol#: 301

C 5732 Deborah Dacus Vol#:

C 5733 Charles Dillmann Vol#: 301

C 5734 Kay Brathol-Hostvet Vol#: 301

C 5735 Sara Kelly Vol#: 301

C 5736 Andrea Lyman Vol#: 301

C 5737 Lisk Lindsay Vol#: 301

C 5738 Teresa & Laura Mueller Vol#: 301

C 5739 John Thompson Vol#: 301

C 5740 Usa Marie Bauer Vol#: 301

C 5741 Bob Osborne Vol#: 301

C 5742 Yvonne Evans Vol#: 301

C 5743 Paul L. Simpson Vol#: 301

C 5744 Jerri Louise Decker Vol#: 301

C 5745 Virginia Mills Vol#: 301

C 5746 Sara Jane Drewry Vol#: 301

C 5748 Crystal Hart Vol#: 301

C 5749 Joan L. Allen Vol#: 301

C 5750 Valerie Buch Vol#: 301

C 5751 Robert C. Haywood Vol#: 301

C 5752 Amy Lynn Avers Vol#: 301

C 5753 Shannon Nottestad Vol#: 301

C 5754 Wilma Jean Milam Vol#: 301

C 5755 James & Valerie Leever Vol#: 301

C 5756 Loraine Bergold Vol#: 301

C 5757 Rita Grovemeyer Vol#: 301

C 5758 Laura Gia Vol#: 301

C 5759 Rose Cahill Vol#: 301

C 5760 Helene Pektai Vol#: 302

C 5761 Brent Blackwelder Vol#: 302

C 5762 Sharon Lee Norton Vol#: 302

C 5763 John Noel Vol#: 302

C 5764 Carolyn Thornton Vol#: 302

C 5765 Margaret E. Graham Vol#: 302

C 5766 Marcia Walker Vol#: 302

C 5767 Annie Griffin Vol#: 302

C 5768 Annie Becker Vol#: 302

C 5769 Florali McGuire Vol#: 302

C 5770 Elvira Guelzow Vol#: 302

C 5771 Marcia E. Herman Vol#: 302

C 5772 Joe Hampton Vol#: 302

C 5773 Gregory Conko Vol#: 302

C 5774 William Roller Vol#: 302

C 5775 Michael Hansen Vol#: 302

C 5776 Dan Cooly Vol#: 302

C 5777 David Drell Vol#: 302

C 5778 J. M. Baine Vol#: 302

C 5779 Bert McGuire Vol#: 302

C 5780 Jeff Maurer Vol#: 302

C 5781 Barbara E. Lee Vol#: 302

C 5782 Maewyn B. Herring Vol#: 302

C 5783 Mr & Mrs D. C. Powell Vol#: 302

C 5784 Sandra Gray Vol#: 302

C 5785 Norma Townsend Vol#: 302

C 5786 Michael & Rose Hanscom Vol#: 302

C 5787 Lynn Matousek Vol#: 302

C 5788 Alice Devendorf Vol#: 302

C 5789 Gary Zehr Vol#: 302

C 5790 Leann Paulson Vol#: 302

C 5791 Sheryl & Thomas Spain Vol#: 302

C 5792 Lois Chandler Vol#: 302

C 5793 Raymond Frasier Vol#: 302

C 5794 Toni Jackson Vol#: 302

C 5795 Linda Judson Vol#: 302

C 5796 John P. Newcomer Vol#: 302

C 5797 Ruth Dingley Vol#: 302

C 5798 Pam Hampton Vol#: 302

C 5799 Gayle Richardson Vol#: 302

C 5800 Joann B. Lally Vol#: 302

C 5801 Dorothy Sucharski Vol#: 302

C 5802 Ruth H. Cooper Vol#: 302

C 5803 Mr & Mrs Michael Contratto Vol#: 302

C 5804 Madeline Prages Vol#: 302

C 5805 Leanna Patwell Vol#: 302

C 5806 Ira Graham Vol#: 302

C 5807 Ron Garner Vol#: 302

C 5808 Mabel Jane Kelly Vol#: 302

C 5809 Joseph Chilberg Vol#: 302

C 5810 Amy Tranter Vol#: 302

C 5811 Mary L. Oney Vol#: 302

C 5812 Deborra Sanders Vol#: 302

C 5813 Carol Painter Vol#: 302

C 5814 Ginger Timberlake Vol#: 302

C 5815 Joanna Kirkpatrick Vol#: 302

C 5816 Gertrude E. Mosca Vol#: 302

C 5817 D. L. Thompson Vol#: 302

C 5818 Sarah Martin Vol#: 302

C 5819 Vicki Noble Vol#:

C 5820 Sally Goddard Vol#: 302

C 5821 Virginia Paine Vol#: 302

C 5822 Mary & Richard Burney Vol#: 302

C 5823 Donald J. Varao Vol#: 302

C 5824 Donn K & Nancy Knox Vol#: 302

C 5825 David J. Novak Vol#: 302

C 5826 Carol Buck Vol#: 302

C 5827 Lillian Cheely Vol#: 302

C 5828 Suzanne Kemman Vol#: 302

C 5829 Vickie Kirsch Vol#: 302

C 52228 Joel & Cindi Armistead Vol#:

99N-4491 Reuse of Single Use Devices proposal

C 108 Raymond Dieter Vol#: 7

99N-4578 Mammography Facilities

BKG 1 DHHS/FDA Vol#: 1

99N-4784 Redacted Version of Substantially-Equivalent Premarket Notif

C 8 Medtronic,Inc. Vol#: 1

C 9 Medical Device Manufacturers Association Vol#: 1

C 10 Smith & Nephew, Inc. Vol#:

C 11 Kleinfeld, Kaplan and Becker Law Offices Vol#: 1

C 12 National Electrical Manufacturers Assoc. Vol#: 1

C 13 Health Industry Manufacturers Assoc. Vol#: 1

C 14 Abbott Laboratories Vol#: 1

C 15 Scimed Life Systems Inc. Vol#: 1

99P-0389 Abbreviated new drug application/topical dematological drug

LET 2 HFD-1 to Pharmacia & Upjohn Vol#: 1

99P-0485 Rescind Approval of Subtherapeutic Antibiotic Use Livestock

C 2450 Jane Whiting Vol#: 185

C 2451 Rhoda Elovitz Vol#: 185

99P-0795 Amend regulations on bottled water

C 13 Gloria Lamb / Eugene Lamb Vol#: 6

C 14 International Dioxcide, Inc. Vol#: 6

C 15 Safe Water Coalition of Washington State Vol#: 6

99P-1418 Methylphenidate Hydrochloride Chewable Tablets, 2.5mg

C 1 Congress of the United States Vol#: 1

99P-2077 Reg/Guide to Label Medical Devices contain'g Phthalate Plast

LET 2 HFZ-1 to Sanford J. Lewis Vol#: 3

99P-2078 ANDA Suitability for methotrexate for oral solution

WDL 2 McKenna & Cuneo Vol#: 1

99P-2733 ANADA for Ketanil 200 (Ketamine Hydrochloride Inj.

PDN 1 HFC-1 to Wildlife Pharmaceuticals Vol#: 1

99P-2852 Condoms Packaging for both latex and non-latex condoms

PAV 1 HFZ-2 to Kleinfeld Kaplan & Becker Vol#: 1

99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol

C 2 Center for Science in the Public Interes Vol#: 1

99P-4209 Hydrocodone Bitartrate & Acetaminophen Tablets

ANS 1 HFD-007 to Mallinckrodt Inc. Vol#: 2

99P-4932 ANDA Suitability Petitions for Parenteral Drugs

SUP 1 Hyman, Phelps & McNamara, P.C. Vol#: 1

99P-5105 ANDA for oxycodone hydrochloride, oxycodone terephthalate

SUP 1 King & Spalding Vol#: 1

99P-5317 Stay of Approval of ANDA for a Generic Version of Enalapril

C 1 Teva Pharmaceuticals USA Inc. Vol#: 1

99P-5330 ANADA for enalapril maleate tablets

LET 1 DHHS/Center for Veterinary Medicine Vol#: 1

00D-0053 Reprocessing&Reuse of Single-Use Devices/Risk Categorization

C 5 Pattyn Karen Vol#: 1

00D-0087 IND meetings for human drugs/biologics,chemistry,mfging

C 1 GlaxoWellcome Inc. Vol#: 1

00H-0007 Civil Money Penalty;Eugene Ball;dba Park City Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0013 Civil Money Penalty;Ted Daniels and Gus Daniels,dba Pronto D

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0021 Civil Money Penalty;Inner City Oil Company,Inc;dba Service

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0023 Civil Money Penalty;John Kelley;dba Nikals Smokes & Photo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0026 Civil Money Penalty;Charles McKenzie and Regina McKenzie

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0028 Civil Money Penalty;Panaro's Pizzeria Inc;dba Panaro's Pizze

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0030 Civil Money Penalty;Bill Trevathan;dba Bill's Market

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0031 Civil Money Penalty;Uni-Marts,Inc;dba Uni-Mart

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0034 Civil Money Penalty;B & D Petroleum Sales, Inc;dba B & D Cit

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0042 Civil Money Penalty;George McCullough;dba Kona Shell

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0044 Civil Money Penalty;James Nash and Peggy Nash;dba P J's Gift

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0046 Civil Money Penalty;John Pleines;dba Pleines Package Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0048 Civil Money Penalty;S & D Enterprises, LLC;dba Unocal 76 Foo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0065 Civil Money Penalty;Go-Mart Inc,dba U-Pak Food Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0066 Civil Money Penalty;Hammer-Williams Company;dba Curve Jiffy

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0075 Civil Money Penalty;Melcam,Inc;dba Mel's Amoco

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0102 Civil Money Penalty;Farman Elahi;dba Chestnut Park Dairy Sto

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0104 Civil Money Penalty;Harold B. Chrisley;dba Shop-EEZ

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0105 Civil Money Penalty;Pritam,Inc;dba Mike Patel;dba One Stop

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0114 Civil Money Penalty;CVS Pharmacy,Inc;dba CVS Pharmacy #5586

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0116 Civil Money Penalty:Fakhoury Enterprises,Inc;dba Flash Food

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0126 Civil Money Penalty;Doyle Ownby;D J's Market #1

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0139 Civil Money Penalty;Jill C. Store Corporation;dba Country

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0140 Civil Money Penalty;Kangs Ju-Ho,Inc;dba Chesley Liquors

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0141 Civil Money Penalty;Chris Kirchenhieter;Brooklyn Amoco Gas

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0173 Civil Money Penalty;Shop-Wise,Inc;dba Moose Hollow General

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0183 Civil Money Penalty;Chin Y. Hwang & Young S. Hwang;dba Clift

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0189 Civil Money Penalty;Burch Oil Co., Inc;dba Mechanicsville

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0190 Civil Money Penalty;Claudio Cejas;dba Nino's Grocery Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0200 Civil Money Penalty;S.Manki Corp;dba Penn Corner

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0209 Civil Money Penalty;Lana Turner;dba CED's Hi Ball Cafe

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0210 Civil Money Penalty;Keeok Yi;dba Connecticut Avenue Liquors

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0214 Civil Money Penalty;SSP Partners,Ltd;dba Circle K #2368

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0215 Civil Money Penalty;Jinhee Suh;dba Colorado Liquor Store

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0239 Civil Money Penalty,Irving Oil Corporation,dba Gorham Irving

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0250 Civil Money Penalty;Dean Bacon and Ann Bacon,dba Maurie's

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0252 Civil Money Penalty;CVS Revco D S Inc,dba CVS Pharmacy #6446

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0253 Civil Money Penalty;Dash In Inc,dba Dash In #7

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0262 Civil Money Penalty;Green Oil Co,dba Illiiopolis Citgo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0263 Civil Money Penalty;Jacinta Hernandez,dba Cesar's Drive In

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0266 Civil Money Penalty;Karen Kabrud Inc,dba Coady's Liquor

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0267 Civil Money Penalty;Kishan Cards & Gifts Inc,dba Gateway Cig

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0270 Civil Money Penalty;Claudio Montero Mora,dba Claudio's Liquo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0277 Civil Money Penalty;Gerich's Service Station Inc,dba Gerich'

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0281 Civil Money Penalty;Larry Meixner,dba Air Bears Restaurant

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0286 Civil Money Penalty;Al Smith & Martha Smith,dba Smith's Shaw

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0290 Civil Money Penalty;Jeff Hoenshell,dba J&S Supermarket

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0298 Civil Money Penalty;Khaled M Ammar,dba Penny Saver Grocery

LET 4 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0299 Civil Money Penalty;Town 7 Market Inc,dba Town 7 Market

LET 4 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0301 Civil Money Penalty;Ramey & Sons Inc,dba Ramey's super Valu

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-0305 Civil Money Penalty;Farmland Ind Inc,dba Wynne Fast Lane 118

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1107 Civil Money Penalty:CVS Revco DS Inc dba CVS Pharmacy 4199

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1108 Civil Money Penalty:Dean Cox dba Duluth Tobacco & Gifts

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1109 Civil Money Penalty:K & J Enterp Inc dba Jimmys Crab House

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1110 Civil Money Penalty:Cloverland Farms Dairy dba Royal Farm

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1111 Civil Money Penalty:Dong Yin Chen dba Lennys Carryout

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1112 Civil Money Penalty:Hankins Services Inc Richard Hankins

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1113 Civil Money Penalty:RH Enterp Inc dba Ray's Crown

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00H-1114 Civil Money Penalty:Howard Hammond dba Hammonds Citgo

LET 2 Office of Tobacco Programs Vol#: 1

WDL 1 GCF-1 Vol#: 1

00N-0504 Egg Safety Action Plan

C 1 Food Safety Consultant Services Vol#: 1

00N-0598 Dietary Supplement Health Claim/Implementation of Pearson De

EAPE66 FDA Vol#: 2

EAPE67 IWP News Vol#: 2

EAPE68 FDA-CFSAN-ONPLDS Vol#: 2

EAPE69 Library of Congress Vol#: 2

EAPE70 Food, Nutrition & Policy Consultants, LL Vol#: 2

EAPE71 Ketchum Public Relations Vol#: 2

EAPE72 Hogan & Hartson Vol#: 2

EC 12 Ms. Karen Zmitrovitch Vol#: 2

EC 13 Ft. Campbell Schools Vol#: 2

EC 14 Mrs. Hilda Vale Vol#: 2

EC 15 Brandywine Nursing Home Vol#: 2

EC 16 Mrs. rhona gerber Vol#: 2

00P-0444 ANADA Suitability for spectinomycin sterile solution

LET 1 DHHS/Center for Veterinary Medicine Vol#: 1

00P-0498 Exempt Swan-Ganz Pacing Catheters and Probes

C 2 Baxter Healthcare Corporation Vol#: 1

C 3 Baxter Healthcare Corporation Vol#: 1

00P-0585 Prozac (Fluoxetine) Tablets Voluntarily Withdrawn

C 1 Stephen Leith Vol#: 1