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Dockets Management

                       
 

Dockets Entered On September 12, 2003

Table of Contents

 
   
   
 
 

Docket #

 

Title

 

1975N-0183H. 1          Health-Care Antiseptic Drug Products for OTC Human Use. 1

1994P-0036. 1             Req labeling of trans fatty acid & prohibit deceptive claims. 1

1997S-0162. 1             30-Day Structure Function Claim Notification Letters Dietary. 1

1998F-0196. 1             Safe use of Selenium Yeast in Animal Feeds. 1

2002N-0178. 1            Canned Tomatoes Deviating from Identity Standard. 1

2003N-0053. 1            Interstate Shellfish Dealers Certificate; Information Collect 1

2003N-0075. 1            Administrative Detention and Banned Med. Devices; Agency Infor 1

2003N-0198. 2            Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License  2

2003N-0369. 2            Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications; Determination That LUVOX (Fluvoxamine Maleate) 25-Milligram (mg), 50-mg, 100-mg, and 150-mg Tablets Was Not Withdrawn. 2

2003N-0376. 2            Medical Devices: Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees  2

2003N-0384. 2            Hoffmann-La Roche, Inc.; Withdrawal of Approval of a New Drug Application. 2

2003V-0428. 2            Laser Light Show. 2

Contents

 

1975N-0183H

 

Health-Care Antiseptic Drug Products for OTC Human Use

 
 
 

C 86          Attachment

 

Cantox Health Sciences International

 

Vol #:

 

198

 
 
 

C 87        Attachments

 

Bode Chemie (Bode)

 

Vol #:

 

199

 
 

 

1994P-0036

 

Req labeling of trans fatty acid & prohibit deceptive claims

 
 
 

NAL 1

 

FDA

 

Vol #:

 

84

 
 
 

SS 1

 

Supporting Statement

 

Vol #:

 

84

 
 

 

1997S-0162

 

30-Day Structure Function Claim Notification Letters Dietary

 
 
 

LET 10883

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10884

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10885

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10886

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10887

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10888

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10889

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10890

 

Enzymatic Therapy Natural medicines

 

Vol #:

 

82

 
 
 

LET 10891

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10892

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10893

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10894

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10895

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10896

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10897

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
                   
 

LET 10898

 

Nature's Life

 

Vol #:

 

82

 
 
 

LET 10899

 

Nature's Life

 

Vol #:

 

82

 
 
 

LET 10900

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10901

 

Herbalife International of America, Inc.

 

Vol #:

 

82

 
 
 

LET 10902

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10903

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10904

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10905

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10906

 

Enzymatic Therapy Naural Medicines

 

Vol #:

 

82

 
 
 

LET 10907

 

Enzymatic Therapy Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10908

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10909

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 
 

LET 10910

 

PhytoPharmica Natural Medicines

 

Vol #:

 

82

 
 

 

1998F-0196

 

Safe use of Selenium Yeast in Animal Feeds

 
 
 

NFR 3

 

FDA

 

Vol #:

 

1

 
 

 

2002N-0178

 

Canned Tomatoes Deviating from Identity Standard

 
 
 

NEC 1

 

FDA

 

Vol #:

 

1

 
 

 

2003N-0053

 

Interstate Shellfish Dealers Certificate; Information Collect

 
 
 

NAL 1

 

FDA

 

Vol #:

 

1

 
 
 

SS 1

 

Supporting Statement

 

Vol #:

 

1

 
 

 

2003N-0075

 

Administrative Detention and Banned Med. Devices; Agency Infor

 
 
 

NAL 1

 

FDA

 

Vol #:

 

1

 
 
 

SS 1

 

Supporting Statement

 

Vol #:

 

1

 
 

 

2003N-0198

 

Agency Information Collection Activities: Proposed Collection; Comment Request; Medicated Feed Mill License

 
 
 

NCR 1

 

FDA

 

Vol #:

 

1

 
 

 

2003N-0369

 

Solvay Pharmaceuticals, Inc.; Withdrawal of Approval of Two New Drug Applications; Determination That LUVOX (Fluvoxamine Maleate) 25-Milligram (mg), 50-mg, 100-mg, and 150-mg Tablets Was Not Withdrawn

 
   
 

NWL 1

 

FDA

 

Vol #:

 

1

 
 

 

2003N-0376

 

Medical Devices: Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees

 
 
 

N 1

 

FDA

 

Vol #:

 

1

 
 

 

2003N-0384

 

Hoffmann-La Roche, Inc.; Withdrawal of Approval of a New Drug Application

 
 
 

NWL 1

 

FDA

 

Vol #:

 

1

 
                   

 

2003V-0428

 

Laser Light Show

 
 
 

ACK 1

 

HFA-305 to Cunningham Products Resources

 

Vol #:

 

1

 
 
 

ACK 2

 

Number not used

 

Vol #:

 

1

 
 
 

ACK 3

 

Number not used

 

Vol #:

 

1

 
 
 

VAR 1

 

Cunningham Products Resources

 

Vol #:

 

1

 

Page created on September 15, 2003
Page updated on October 1, 2003 jb

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