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DOCKETS MANAGEMENT

 

Dockets Entered On July 15, 2003

Table of Contents (Linked)

 

 

Docket #

 

Title

 

 

1991N-0245

 

Cosmetic Products Containing Certain Hormone Ingredients

 

 

1997S-0163

 

Dietary Supplements, Courtesy Letters (Letters of Objection)

 

 

2002D-0515

 

Health Claims labeling conventional foods/dietary supplement

 

 

2002N-0434

 

Withdrawal of Certain Proposed rules & other propose action

 

 

2002N-0500

 

Classification of Silicone Sheeting

 

 

2002P-0447

 

Immediately revoke its acceptance for NDA 21-435 for amlodin

 

 

2003P-0315

 

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

 

Contents

 

1990V-0031

 

Lasermedia Series Projectors, Spectra Phycis Series Lasers

 

 

 

 

 

VRA 7

 

HFZ-300 to Laser Rentals, Inc.

 

Vol #:

 

1

 

 

 

1991N-0245

 

Cosmetic Products Containing Certain Hormone Ingredients

 

 

C 5

 

American Association for Health Freedom

 

Vol #:

 

2

 

 

 

C 6

 

Arizona Cancer Center

 

Vol #:

 

2

 

 

 

C 7

 

National Women's Health Resource Center (NWHRC)

 

Vol #:

 

2

 

 

 

C 8

 

Sastun Center for Integrative Health Care

 

Vol #:

 

2

 

 

 

1997S-0163

 

Dietary Supplements, Courtesy Letters (Letters of Objection)

 

 

LET 706

 

HFS-800 to Nutritional Specialties, Inc.

 

Vol #:

 

21

 

 

 

1998P-0151

 

Introduction Of Downed Cattle Into The Food Supply

 

 

 

 

 

C 6727

 

Sandy Polsky

 

Vol #:

 

284

 

 

 

C 6728

 

Patti Morris

 

Vol #:

 

284

 

 

 

C 6729

 

Annette & Jim Brooks

 

Vol #:

 

284

 

 

 

C 6730

 

Brenda Frey

 

Vol #:

 

284

 

 

 

EMC 3407

 

Liz Lund

 

Vol #:

 

281

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EMC 3408

 

Hayley Silverman, M.S.

 

Vol #:

 

281

 

 

 

EMC 3409

 

Jerri Miller

 

Vol #:

 

281

 

 

 

EMC 3410

 

Michelle Rappaport

 

Vol #:

 

281

 

 

 

EMC 3411

 

Heather Proctor

 

Vol #:

 

281

 

 

 

EMC 3412

 

Raquel Bild-Libbin, Ph.D.

 

Vol #:

 

281

 

 

 

EMC 3413

 

Daniel Sliverman

 

Vol #:

 

281

 

 

 

EMC 3414

 

Rachaud Smith

 

Vol #:

 

281

 

 

 

EMC 3415

 

Edwin Hunter

 

Vol #:

 

281

 

 

 

EMC 3416

 

Dr. Joyce Bloom

 

Vol #:

 

281

 

 

 

EMC 3417

 

Frances Tutt

 

Vol #:

 

281

 

 

 

2000V-1323

 

Laser Light Show

 

 

 

 

 

VRA 2

 

HFZ-300 to Allen Memorial Planetarium

 

Vol #:

 

1

 

 

 

2001P-0230

 

Domestic Marketing & Importation of Transgenic Fish

 

 

 

 

 

C 1338

 

John Saemann

 

Vol #:

 

233

 

 

 

EMC 2929

 

Dana Erickson

 

Vol #:

 

252

 

 

 

EMC 2930

 

Lisamarie McGrath

 

Vol #:

 

252

 

 

 

EMC 2931

 

Andrew McGrath

 

Vol #:

 

252

 

 

 

EMC 2932

 

Joshua Lee

 

Vol #:

 

252

 

 

 

EMC 2933

 

Gregory Williams

 

Vol #:

 

252

 

 

 

EMC 2934

 

Alice Neff

 

Vol #:

 

252

 

 

 

EMC 2935

 

Nikki Sexton

 

Vol #:

 

252

 

 

 

EMC 2936

 

Maura Butler

 

Vol #:

 

252

 

 

 

EMC 2937

 

Amy Brown

 

Vol #:

 

252

 

 

 

EMC 2938

 

Rita Condon

 

Vol #:

 

252

 

 

 

EMC 2939

 

Harriet Sharp

 

Vol #:

 

252

 

 

 

EMC 2940

 

Deana Jewett

 

Vol #:

 

252

 

 

 

EMC 2941

 

Virginia Miller

 

Vol #:

 

252

 

 

 

EMC 2942

 

James L. & Ade K. Reed

 

Vol #:

 

252

 

 

 

EMC 2943

 

Phyllis Aniya Sladek

 

Vol #:

 

252

 

 

 

EMC 2944

 

Betty J. Lambert

 

Vol #:

 

252

 

 

 

EMC 2945

 

Adrienne Lord

 

Vol #:

 

252

 

 

 

EMC 2946

 

Stephen Vallus

 

Vol #:

 

252

 

 

 

EMC 2947

 

Rodger Silvers

 

Vol #:

 

252

 

 

 

EMC 2948

 

Kathryn Lykins

 

Vol #:

 

252

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EMC 2949

 

Barbara Wood

 

Vol #:

 

252

 

 

 

EMC 2950

 

Richard Spotts

 

Vol #:

 

252

 

 

 

EMC 2951

 

Alice Mitchell

 

Vol #:

 

252

 

 

 

EMC 2952

 

Ashley Mitchell

 

Vol #:

 

252

 

 

 

EMC 2953

 

Deborah Lawhorne

 

Vol #:

 

252

 

 

 

EMC 2954

 

Martha Castillo

 

Vol #:

 

252

 

 

 

EMC 2955

 

Joan Olawski-Stiener

 

Vol #:

 

252

 

 

 

EMC 2956

 

number not used

 

Vol #:

 

252

 

 

 

EMC 2957

 

Julie Meadows

 

Vol #:

 

252

 

 

 

EMC 2958

 

Lauren Pennington

 

Vol #:

 

252

 

 

 

EMC 2959

 

Edna Rankine

 

Vol #:

 

252

 

 

 

EMC 2960

 

Margaret Pallas

 

Vol #:

 

252

 

 

 

EMC 2961

 

Frank Stoffers

 

Vol #:

 

252

 

 

 

EMC 2962

 

Eric Adams

 

Vol #:

 

252

 

 

 

EMC 2963

 

Megan Mishou

 

Vol #:

 

252

 

 

 

EMC 2964

 

Barry Goldwater

 

Vol #:

 

252

 

 

 

EMC 2965

 

Mark Schindler

 

Vol #:

 

252

 

 

 

EMC 2966

 

Paul & Judy Wilcox

 

Vol #:

 

252

 

 

 

EMC 2967

 

E. Michael Pearl

 

Vol #:

 

252

 

 

 

EMC 2968

 

Talia Wang

 

Vol #:

 

252

 

 

 

EMC 2969

 

Bonita Poulin

 

Vol #:

 

252

 

 

 

EMC 2970

 

Jeanette Campbell

 

Vol #:

 

252

 

 

 

EMC 2971

 

Shelly Daniels

 

Vol #:

 

252

 

 

 

EMC 2972

 

Deborah Harvey

 

Vol #:

 

252

 

 

 

EMC 2973

 

Dr. Ron Wish

 

Vol #:

 

252

 

 

 

EMC 2974

 

C. D. Allen

 

Vol #:

 

252

 

 

 

EMC 2975

 

David Paul Xavier Burch

 

Vol #:

 

252

 

 

 

EMC 2976

 

Laura Bethea

 

Vol #:

 

252

 

 

 

EMC 2977

 

Sara Denman

 

Vol #:

 

252

 

 

 

EMC 2978

 

Tara Fulgenzi

 

Vol #:

 

252

 

 

 

EMC 2979

 

Clay Henderson

 

Vol #:

 

252

 

 

 

EMC 2980

 

Courtney Downs

 

Vol #:

 

252

 

 

 

EMC 2981

 

Kelly Costin

 

Vol #:

 

252

 

 

 

2002D-0515

 

Health Claims labeling conventional foods/dietary supplement

 

 

C 5

 

Grocery Manufacturers of America

 

Vol #:

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

C 6

 

Alliance for Retired Americans, Center for Science in the Public Interest, et al

 

Vol #:

 

1

 

 

 

2002N-0275

 

Bioterrorism Preparedness; Administrative Detention

 

 

 

 

EMC 79

 

Argentina Government

 

Vol #:

 

8

 

 

 

2002N-0354

 

Long-term Antibiotic Drug Therapy Involving Anthrax;Emergenc

 

 

 

 

 

SS 2

 

HFA-250

 

Vol #:

 

1

 

 

 

2002N-0434

 

Withdrawal of Certain Proposed rules & other propose action

 

 

C 4

 

American Association for Health Freedom

 

Vol #:

 

1

 

 

 

C 5

 

Arizona Cancer Center

 

Vol #:

 

1

 

 

 

C 6

 

National Women's Health Research Center (NWHRC)

 

Vol #:

 

1

 

 

 

C 7

 

Sastun Center of Integrative Health Care

 

Vol #:

 

1

 

 

 

EXT 2

 

Venable Baetjer Howard & Civiletti LLP

 

Vol #:

 

1

 

 

 

2002N-0500

 

Classification of Silicone Sheeting

 

 

C 2

 

National Center for Policy Research for Women and Families (CPR)

 

Vol #:

 

1

 

 

 

2002P-0447

 

Immediately revoke its acceptance for NDA 21-435 for amlodin

 

 

RC 2

 

Pfizer, Inc

 

Vol #:

 

1

 

 

 

SUP 2

 

Dr. Reddy's Laboratories, Inc.

 

Vol #:

 

1

Attachment

 

 

2003P-0315

 

Doxycycline hyclate tablets 20 mg in which bioequivalence of the Mutual product to CollaGened Periostat , the reference listed drug

 

 

ACK 1

 

HFA-305 to CollaGenex Pharmaceuticals, Inc.

 

Vol #:

 

1

 

 

 

CP 1

 

CollaGenex Pharmaceuticals

 

Vol #:

 

1

 

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