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DOCKETS MANAGEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

Dockets Entered On June 4, 2003

TABLE OF CONTENTS

 

 

 

 

 

 

 

 

 

Docket #

 

Title

 

 

 

 

 

 

 

1995P-0246

 

Regulatory Action to Prohibit Misleading Food Labeling

 

 

1997P-0130

 

Require Percentage Ingredient Labeling

 

 

1997S-0163

 

Dietary Supplements, Courtesy Letters (Letters of Objection)

 

 

1998D-0785

 

Medical imaging drugs and biologics

 

 

1998P-0610

 

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

 

 

1999P-2547

 

Alendronate Sodium Tablets

 

 

2000N-1484

 

Safety Reporting Requirements Human Drug/Biological Products

 

 

2002N-0204

 

Bar Code Label Requirements for human drug products

 

 

2002P-0363

 

NDA 20-560: Fosamax (Alendronate Sodium Tablets)

 

 

2003P-0227

 

ANDA Suitability Petition for Cefoxitin

 

DETAILS

 

 

1994P-0036

 

Req labeling of trans fatty acid & prohibit deceptive claims

 

 

EMC 548

 

Kimberly Barnhart

 

Vol #:

 

72

 

 

 

 

1995N-0304

 

Ephedrine Alkaloids: Reports of Adverse Events; Availability

 

 

EMC 777

 

Bobby Cagle

 

Vol #:

 

375

 

 

 

 

EMC 778

 

Rita Kinney

 

Vol #:

 

375

 

 

 

 

EMC 779

 

Karen

 

Vol #:

 

375

 

 

 

 

EMC 780

 

No signature

 

Vol #:

 

375

 

 

 

 

EMC 781

 

James J. Farrell, III

 

Vol #:

 

375

 

 

 

 

EMC 782

 

No signature

 

Vol #:

 

375

 

 

 

 

EMC 783

 

Juliann

 

Vol #:

 

375

 

 

 

 

EMC 784

 

Skylar

 

Vol #:

 

375

 

 

 

 

EMC 785

 

Marianne McLaughlin

 

Vol #:

 

375

 

 

 

 

EMC 786

 

Martin Cooper

 

Vol #:

 

375

 

 

 

 

EMC 787

 

James & Julie Bencin

 

Vol #:

 

375

 

 

 

 

EMC 788

 

Elizabeth Meyette

 

Vol #:

 

375

 

 

 

 

1995P-0246

 

Regulatory Action to Prohibit Misleading Food Labeling

 

 

C 446

 

Center for Science in the Public Interest

 

Vol #:

 

30

Attachment

 

 

 

 

1996N-0417

 

CGMP in Mfg. Packing or Holding Dietary Supplements

 

 

 

EMC 20

 

Rosemary Grutt

 

Vol #:

 

17

 

 

 

 

 

1997P-0130

 

Require Percentage Ingredient Labeling

 

 

 

 

 

 

 

C 170

 

Center for Science in the Public Interest (CSPI)

 

Vol #:

 

5

 

 

 

 

 

1997S-0163

 

Dietary Supplements, Courtesy Letters (Letters of Objection)

 

 

 

LET 695

 

HFS-800 to Indiana Botanic Gardens, Inc.

 

Vol #:

 

21

 

 

 

 

 

LET 696

 

HFS-800 to Blaine Pharmaceuticals

 

Vol #:

 

21

 

 

 

 

 

LET 697

 

HFS-800 to Flora, Inc.

 

Vol #:

 

21

 

 

 

 

 

LET 698

 

HFS-800 to Mason Vitamins, Inc.

 

Vol #:

 

21

 

 

 

 

 

LET 699

 

HFS-800 to RLP Enterprises

 

Vol #:

 

21

 

 

 

 

 

LET 700

 

HFS-800 to 21st Century Nutritional Products, Inc.

 

Vol #:

 

21

 

 

 

 

 

LET 701

 

HFS-800 to Amasia Acupuncture & Herbs Ltd.

 

Vol #:

 

21

 

 

 

 

 

1998D-0785

 

Medical imaging drugs and biologics

 

 

 

 

 

 

 

EMC 3

 

Vanderbilt University

 

Vol #:

 

5

 

 

 

 

 

1998D-1146

 

Microbial effects of antimicrobial new animal drugs/human

 

 

 

EMC 680

 

L.A. Tremaine

 

Vol #:

 

19

 

 

 

 

 

1998P-0610

 

Convert Allegra/Allegra-D,Claritin/Claritin-D,Zyrtec to OTC

 

 

 

EMC 88

 

American Academy of Otolaryngic allergy (AAOA)

 

Vol #:

 

5

 

 

 

 

 

EMC 89

 

Washington Legal Foundation

 

Vol #:

 

5

 

 

 

 

 

1999N-4282

 

Biotechnology in the Year 2000 and Beyond; Public Meetings

 

 

 

EMC 3993

 

Andrew Rhodes

 

Vol #:

 

514

 

 

 

 

 

EMC 3994

 

Andrew McGrath

 

Vol #:

 

514

 

 

 

 

 

EMC 3995

 

Lisamarie McGrath

 

Vol #:

 

514

 

 

 

 

 

EMC 3996

 

PJ Perkins

 

Vol #:

 

514

 

 

 

 

 

EMC 3997

 

Nikki Sexton

 

Vol #:

 

514

 

 

 

 

 

EMC 3998

 

Nicole Cherok

 

Vol #:

 

514

 

 

 

 

 

EMC 3999

 

John Crockett

 

Vol #:

 

514

 

 

 

 

 

1999P-1340

 

Declared Eternity eau de Parfum Misbranded

 

 

 

EMC 446

 

Greg Rockwood

 

Vol #:

 

21

 

 

 

 

 

EMC 447

 

Connie Jo Gandy

 

Vol #:

 

21

 

 

 

 

 

EMC 448

 

Brenda Tayler

 

Vol #:

 

21

 

 

 

EMC 449

 

Sabrina C. Corona

 

Vol #:

 

21

 

 

 

EMC 450

 

Ray W. Goodrich

 

Vol #:

 

21

 

 

 

EMC 451

 

Hussam Hussin

 

Vol #:

 

21

 

 

 

EMC 452

 

Virginia L. Mott

 

Vol #:

 

21

 

 

 

1999P-2547

 

Alendronate Sodium Tablets

 

 

LET 1

 

Merck Research Laboratories

 

Vol #:

 

1

 

 

 

1999P-4613

 

Revoke the Regulation That Approved Posilac

 

 

EMC 2421

 

Michael J. Potter

 

Vol #:

 

46

 

 

 

2000N-1484

 

Safety Reporting Requirements Human Drug/Biological Products

 

 

EMC 5

 

Washington University Medical Center of St. Louis

 

Vol #:

 

3

 

 

 

2001P-0075

 

Switch Status of Emergency Contraceptives from Rx to OTC

 

 

 

 

 

EMC 323

 

Trenna Louise Lawson

 

Vol #:

 

39

 

 

 

EMC 324

 

Daniel H. Levine

 

Vol #:

 

39

 

 

 

EMC 325

 

Elizabeth Cardwell

 

Vol #:

 

39

 

 

 

EMC 326

 

Russell Engebretson

 

Vol #:

 

39

 

 

 

EMC 327

 

Suzanne Boles

 

Vol #:

 

39

 

 

 

EMC 328

 

Elisa Hurley

 

Vol #:

 

39

 

 

 

EMC 329

 

No signature

 

Vol #:

 

39

 

 

 

EMC 330

 

No signature

 

Vol #:

 

39

 

 

 

EMC 331

 

Tracey Sherman

 

Vol #:

 

39

 

 

 

EMC 332

 

Hope Martinson

 

Vol #:

 

39

 

 

 

EMC 333

 

Kelly McVicker

 

Vol #:

 

39

 

 

 

EMC 334

 

Jacqueline Guzman

 

Vol #:

 

39

 

 

 

EMC 335

 

Marcy Clements

 

Vol #:

 

39

 

 

 

EMC 336

 

Linda W. Prine, MD

 

Vol #:

 

39

 

 

 

EMC 337

 

Alice J. Alburo

 

Vol #:

 

39

 

 

 

EMC 338

 

Amy Abbott

 

Vol #:

 

39

 

 

 

EMC 339

 

Assaf Yosha, MD

 

Vol #:

 

39

 

 

 

EMC 340

 

Patty Frew

 

Vol #:

 

39

 

 

 

EMC 341

 

Annie Mehlman

 

Vol #:

 

39

 

 

 

EMC 342

 

Angelina Blackmon

 

Vol #:

 

39

 

 

 

EMC 343

 

Lisette Caveny

 

Vol #:

 

39

 

 

 

EMC 344

 

No signature

 

Vol #:

 

39

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EMC 345

 

Emily Berger

 

Vol #:

 

39

 

 

 

 

 

EMC 346

 

Stacey Freeman

 

Vol #:

 

39

 

 

 

 

 

EMC 347

 

C. Degerinis

 

Vol #:

 

39

 

 

 

 

 

EMC 348

 

Bill Hahn

 

Vol #:

 

39

 

 

 

 

 

EMC 349

 

Nick Gideonse, MD

 

Vol #:

 

39

 

 

 

 

 

EMC 350

 

No signature

 

Vol #:

 

39

 

 

 

 

 

EMC 351

 

Alexandria Aitken,MHA

 

Vol #:

 

39

 

 

 

 

 

EMC 352

 

Lisa Clancy

 

Vol #:

 

39

 

 

 

 

 

EMC 353

 

Jennie Weems

 

Vol #:

 

39

 

 

 

 

 

EMC 354

 

Anne Kaufhold

 

Vol #:

 

39

 

 

 

 

 

EMC 355

 

Susan E. Rubin, MD

 

Vol #:

 

39

 

 

 

 

 

EMC 356

 

Nancy Moran

 

Vol #:

 

39

 

 

 

 

 

EMC 357

 

Judith & Harold Rubin

 

Vol #:

 

39

 

 

 

 

 

EMC 358

 

Billie Campbell

 

Vol #:

 

39

 

 

 

 

 

EMC 359

 

Jo Ann Howse

 

Vol #:

 

39

 

 

 

 

 

EMC 360

 

JuLayne Sawyer Trimble

 

Vol #:

 

39

 

 

 

 

 

EMC 361

 

Tiffany Reed

 

Vol #:

 

39

 

 

 

 

 

EMC 362

 

Ruth Lesnewski

 

Vol #:

 

39

 

 

 

 

 

EMC 363

 

Elizabeth Giles

 

Vol #:

 

39

 

 

 

 

 

EMC 364

 

Laura Rubin-Rieck

 

Vol #:

 

39

 

 

 

 

 

EMC 365

 

Anita Flora

 

Vol #:

 

39

 

 

 

 

 

EMC 366

 

Dallas Ferguson

 

Vol #:

 

39

 

 

 

 

 

EMC 367

 

Mike Fuller

 

Vol #:

 

39

 

 

 

 

 

EMC 368

 

Samantha Evans

 

Vol #:

 

39

 

 

 

 

 

EMC 369

 

Erica L. Brody,MD

 

Vol #:

 

39

 

 

 

 

 

EMC 370

 

Ruth Steinberg,MD

 

Vol #:

 

39

 

 

 

 

 

EMC 371

 

Rebecca Ray

 

Vol #:

 

39

 

 

 

 

 

EMC 372

 

Ava Rosaland Moskin,MD

 

Vol #:

 

39

 

 

 

 

 

EMC 373

 

Debby Copes, MD

 

Vol #:

 

39

 

 

 

 

 

EMC 374

 

Eileen Lehmann

 

Vol #:

 

39

 

 

 

 

 

EMC 375

 

Ried Crowe

 

Vol #:

 

39

 

 

 

 

 

EMC 376

 

Carol Davis McDonald

 

Vol #:

 

39

 

 

 

 

 

EMC 377

 

Kathy Simmonds,MSN,RNC,MPH

 

Vol #:

 

39

 

 

 

 

 

EMC 378

 

Ed & Chris Levine

 

Vol #:

 

39

 

 

 

 

 

EMC 379

 

Betsy Flagler

 

Vol #:

 

39

 

 

 

 

 

EMC 380

 

Naomi Feiner

 

Vol #:

 

39

 

 

 

 

 

EMC 381

 

Rosemary E. King

 

Vol #:

 

39

 

 

 

EMC 382

 

Joe Eldred

 

Vol #:

 

39

 

 

 

EMC 383

 

Anne McEnany

 

Vol #:

 

39

 

 

 

EMC 384

 

Tanya Baybo

 

Vol #:

 

39

 

 

 

EMC 385

 

Adam Grabois

 

Vol #:

 

39

 

 

 

EMC 386

 

Suzanne E. Mueller

 

Vol #:

 

39

 

 

 

EMC 387

 

Pasquale & Mary Landolfi

 

Vol #:

 

39

 

 

 

EMC 388

 

Angela Postal

 

Vol #:

 

39

 

 

 

EMC 389

 

Hayes Greenfield

 

Vol #:

 

39

 

 

 

EMC 390

 

Kathleen Connolly

 

Vol #:

 

39

 

 

 

EMC 391

 

Nancy Greenfield

 

Vol #:

 

39

 

 

 

EMC 392

 

Alice Henson

 

Vol #:

 

39

 

 

 

EMC 393

 

Nicole Fanarjian,MD

 

Vol #:

 

39

 

 

 

EMC 394

 

Eileen Schnitger

 

Vol #:

 

39

 

 

 

EMC 395

 

Tess Bobo,DO

 

Vol #:

 

39

 

 

 

EMC 396

 

Melissa Serpas

 

Vol #:

 

39

 

 

 

EMC 397

 

Karen Rood

 

Vol #:

 

39

 

 

 

EMC 398

 

Dorothy L. Gaither

 

Vol #:

 

39

 

 

 

EMC 399

 

Rachel Ballard, MD

 

Vol #:

 

39

 

 

 

EMC 400

 

Sandra Burge

 

Vol #:

 

39

 

 

 

EMC 401

 

Amy Jo Goddard

 

Vol #:

 

39

 

 

 

EMC 402

 

Sheila Harris

 

Vol #:

 

39

 

 

 

EMC 403

 

Shana Avery

 

Vol #:

 

39

 

 

 

EMC 404

 

Mary Clark

 

Vol #:

 

39

 

 

 

EMC 405

 

Andrea Arena

 

Vol #:

 

39

 

 

 

EMC 406

 

Betty Banner

 

Vol #:

 

39

 

 

 

EMC 407

 

Beth Tarbell

 

Vol #:

 

39

 

 

 

EMC 408

 

Robin Klinger

 

Vol #:

 

39

 

 

 

EMC 409

 

Barbara Crook

 

Vol #:

 

39

 

 

 

EMC 410

 

Robert Sassone

 

Vol #:

 

39

 

 

 

EMC 411

 

David Paul Xavier Burch

 

Vol #:

 

39

 

 

 

EMC 412

 

Rhonda Borelli

 

Vol #:

 

39

 

 

 

EMC 413

 

Nancy Guinn, MD

 

Vol #:

 

39

 

 

 

EMC 414

 

Dr. & Mrs Burton H. Bartley

 

Vol #:

 

39

 

 

 

EMC 415

 

Maria A. Gonzalez

 

Vol #:

 

39

 

 

 

EMC 416

 

Daniel J. Gorman

 

Vol #:

 

39

 

 

 

EMC 417

 

Diane DiSalvo,RN

 

Vol #:

 

39

 

 

 

EMC 418

 

Karen L. Brauer,MS,RPh

 

Vol #:

 

39

 

 

 

EMC 419

 

Dr. Ellen Hufbauer

 

Vol #:

 

39

 

 

 

 

EMC 420

 

No signature

 

Vol #:

 

39

 

 

 

 

EMC 421

 

Michelle Bloodworth

 

Vol #:

 

39

 

 

 

 

EMC 422

 

Jules Eckersley,MD

 

Vol #:

 

39

 

 

 

 

EMC 423

 

Jessica L. Bloom-Foster,MD

 

Vol #:

 

39

 

 

 

 

EMC 424

 

John Mancini

 

Vol #:

 

39

 

 

 

 

EMC 425

 

Kathleen Waits

 

Vol #:

 

39

 

 

 

 

EMC 426

 

Joe Davanzo

 

Vol #:

 

39

 

 

 

 

EMC 427

 

Anne Collins

 

Vol #:

 

39

 

 

 

 

EMC 428

 

Jered Egan

 

Vol #:

 

39

 

 

 

 

EMC 429

 

William Depner

 

Vol #:

 

39

 

 

 

 

EMC 430

 

Judy Robinson

 

Vol #:

 

39

 

 

 

 

EMC 431

 

Jason and Andrea Stern

 

Vol #:

 

39

 

 

 

 

EMC 432

 

Rick Bonner

 

Vol #:

 

39

 

 

 

 

EMC 433

 

Kathy R. Madere

 

Vol #:

 

39

 

 

 

 

EMC 434

 

Carolyn A. Torrence

 

Vol #:

 

39

 

 

 

 

EMC 435

 

Rosemary Gunsett

 

Vol #:

 

39

 

 

 

 

EMC 436

 

Ellen L. Markham

 

Vol #:

 

39

 

 

 

 

EMC 437

 

Elizabeth Deiermann

 

Vol #:

 

39

 

 

 

 

EMC 438

 

Jeanie Achord

 

Vol #:

 

39

 

 

 

 

EMC 439

 

Angela Decoteau

 

Vol #:

 

39

 

 

 

 

EMC 440

 

Deborah D. Whittaker

 

Vol #:

 

39

 

 

 

 

EMC 441

 

Charmin T. Simon

 

Vol #:

 

39

 

 

 

 

EMC 442

 

Dolores Singer

 

Vol #:

 

39

 

 

 

 

EMC 443

 

Deborah Smith

 

Vol #:

 

39

 

 

 

 

EMC 444

 

Guy A. Sigorino

 

Vol #:

 

39

 

 

 

 

EMC 445

 

Rita Issinghoff

 

Vol #:

 

39

 

 

 

 

2002N-0204

 

Bar Code Label Requirements for human drug products

 

EMC 175

 

Reconnaissance Intl

 

Vol #:

 

13

 

 

 

 

EMC 176

 

intelliDOT Corp.

 

Vol #:

 

13

 

 

 

 

2002P-0363

 

NDA 20-560: Fosamax (Alendronate Sodium Tablets)

 

LET 1

 

Merck Research Laboratories

 

Vol #:

 

1

 

 

 

 

2003P-0227

 

ANDA Suitability Petition for Cefoxitin

 

ACK 1

 

HFA-305 to Samson Medical Technologies, LLC

 

Vol #:

 

1

 

 

CP 1

 

Samson Medical Technologies, LLC

 

Vol #:

 

1

Exhibit a

Exhibit b

Exhibit c

 

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