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DOCKETS MANAGEMENT

 

 

 

 

 

 

 

 

 

 

 

 

Dockets Entered On June 3, 2003

 

TABLE OF CONTENTS

 

 

 

 

 

 

Docket #

 

Title

 

1975N-0183H

 

Health-Care Antiseptic Drug Products for OTC Human Use

 

 

1981N-0033P

 

Antiplaque & Antiplaque-Related Claims

 

 

1994P-0036

 

Req labeling of trans fatty acid & prohibit deceptive claims

 

 

1999D-0674

 

Investigational new drug applications for phase 2&3 of drugs

 

 

2000N-1396

 

Bioengineered Foods Consumed By Humans or Animals

 

 

2001D-0224

 

Mass Spectrometry for Confirmation of Identity of Animal Drug Residues

 

 

2003D-0197

 

Guidance for Industry on Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate -- Labeling Enforcement Policy; Availability

 

 

2003N-0034

 

FDA Safety Alert/ Public Health Advisory Readership Survey

 

 

2003P-0196

 

Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status

 

 

2003P-0216

 

ANDA for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan B 0.75 mg Levonorgestrel tablet) in strength

 

 

2003P-0217

 

Concept of shared exclusivity for multiple ANDA submitted on the same day

 

 

DETAILS

 

 

 

 

1975N-0183H

 

Health-Care Antiseptic Drug Products for OTC Human Use

 

 

 

 

 

NPR 2

 

FDA

 

Vol #:

 

149

 

 

1981N-0033P

 

Antiplaque & Antiplaque-Related Claims

 

 

 

 

 

BKG 2

 

Background Material (Refs 1-467)

 

Vol #:

 

13

 

 

NAP 1

 

FDA

 

Vol #:

 

12

 

 

1994P-0036

 

Req labeling of trans fatty acid & prohibit deceptive claims

 

 

 

 

 

ACK 2

 

HFA-305 to Bantransfats.com

 

Vol #:

 

72

 

 

CP 2

 

Bantransfats.com

 

Vol #:

 

72

 

 

1999D-0674

 

Investigational new drug applications for phase 2&3 of drugs

 

 

 

 

 

GDL 2

 

GUIDANCE

 

Vol #:

 

1

 

 

NAD 2

 

FDA

 

Vol #:

 

1

 

 

2000N-1396

 

Bioengineered Foods Consumed By Humans or Animals

 

 

 

 

 

EMC 11563

 

PJ Perkins

 

Vol #:

 

349

 

 

EMC 11564

 

Jackie and Chris Stover

 

Vol #:

 

349

 

 

2001D-0224

 

Mass Spectrometry for Confirmation of Identity of Animal Drug Residues

 

 

 

 

 

GDL 2

 

GUIDANCE

 

Vol #:

 

1

 

 

NAD 2

 

FDA

 

Vol #:

 

1

 

 

2003D-0197

 

Guidance for Industry on Drug Products Containing Ensulizole, Hypromellose, Meradimate, Octinoxate, and Octisalate -- Labeling Enforcement Policy; Availability

 

 

GDL 1

GUIDANCE

 

Vol #:

 

1

 

 

NAD 1

FDA

 

Vol #:

 

1

 

 

2003N-0034

FDA Safety Alert/ Public Health Advisory Readership Survey

 

 

 

 

N 2

FDA

 

Vol #:

 

1

 

 

2003P-0196

Switch Nicotrol Inhaler (nicotine Inhalation System) From Prescription to Over the Counter Status

 

 

 

 

ACK 1

HFA-305 to Pharmacists Planning Services, inc.

 

Vol #:

 

1

 

 

2003P-0216

ANDA for a drug product(1.5 mg levonorgestrel tablet) in strength(Plan B 0.75 mg Levonorgestrel tablet) in strength

 

 

 

 

ACK 1

HFA-305 to HRA PHARMA

 

Vol #:

 

1

 

 

2003P-0217

Concept of shared exclusivity for multiple ANDA submitted on the same day

 

 

 

 

ACK 1

HFA-305 to Venable, Baeitjer, Howard & Civiletti

 

Vol #:

 

1

 

 

 

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