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DOCKETS MANAGEMENT

 

Dockets Entered On July 8, 2003

Table of Contents (Linked)

 

 

Docket #

 

Title

 

 

2003P-0307

 

ANDA suitability for a new strength of Wararin Sodium Tablets, USP 1.5mg

 

Contents

 

1988F-0182

 

STYRENE-BUTADIENE-ACRYLONITRILE COPOLYMERS

 

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1988F-0340

 

POLY-1-BUTENE RESINS/BUTENE/ETHYLENE COPOLYMERS

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1992F-0315

 

Safe Use of Rubber-Modified Polystyrene; Use of Octadecyl 3

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1994F-0290

 

Safe use of ethylene-1,4-cyclohexylene dimethylene

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1995F-0021

 

Safe Use Of Ethylene Terephthalate-Isophthalate Copolymers

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1997F-0170

 

Polyester-epoxy-urethane Adhesive for use as nonfood contact

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1997F-0284

 

Resinous and Polymeric Coatings in Contact with Food

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1998F-0391

 

C.I. Pigment Red 178

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1998F-0706

 

Colorants for Polymers

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1999F-0720

 

Safe use hydrogenated aromatic petroleum hydrocarbon

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

1999F-4694

 

2-methyl-4-isothiazolin-3-one as an antimicrobial

 

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

2000F-1366

 

Methylmethacrylate-trimethylolpropane Trimethacrylate Copoly

 

 

 

 

 

NWL 1

 

FDA

 

Vol #:

 

1

 

 

 

2000N-1396

 

Bioengineered Foods Consumed By Humans or Animals

 

 

 

 

 

EMC 11566

 

Eli Sterling

 

Vol #:

 

349

 

 

 

EMC 11567

 

Erik Callaway

 

Vol #:

 

349

 

 

 

2000N-1571

 

Enrofloxacin for Poultry: Opportunity for Hearing

 

 

 

 

 

EXB 21

 

Bayer Corporation

 

Vol #:

 

379

 

 

 

EXB 22

 

Bayer Corporation

 

Vol #:

 

379

 

 

 

EXB 23

 

Bayer Corporation

 

Vol #:

 

379

 

 

 

EXB 24

 

Bayer Corporation

 

Vol #:

 

379

 

 

 

2000P-0685

 

Revise of Yogurt Standards

 

 

 

 

 

 

NAP 1

 

FDA

 

Vol #:

 

1

 

 

 

2002D-0080

 

Streamlining Donor Interview Process: Recommendations for

 

 

 

 

 

GDL 2

 

Guideline

 

Vol #:

 

1

 

 

 

NAD 2

 

FDA

 

Vol #:

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2002N-0277

 

Bioterrorism; Establishment & Maintenance of Records

 

 

 

 

 

EC 49

 

Chino, Yasuyuki

 

Vol #:

 

8

 

 

 

2002N-0354

 

Long-term Antibiotic Drug Therapy Involving Anthrax;Emergenc

 

 

 

 

 

NAL 2

 

FDA

 

Vol #:

 

1

 

 

 

2002N-0496

 

Large & Small Volume Parenterals Used in Total Parenteral Nu

 

 

 

 

 

NAL 1

 

FDA

 

Vol #:

 

1

 

 

 

2002P-0177

 

Health Claim: D-tagatose and Noncariogenicity

 

 

 

 

 

NFR 1

 

FDA

 

Vol #:

 

2

 

 

 

2003N-0066

 

Inspection by Accredited Persons Under MDUFMA

 

 

 

 

 

 

SS 1

 

Supporting Statement

 

Vol #:

 

1

 

 

 

2003N-0201

 

Minimizing Medication Errors - Methods for Evaluating Proprietary Names for their Confusion Potential; Public Meeting

 

 

 

 

 

 

NCR 2

 

FDA

 

Vol #:

 

1

 

 

 

2003N-0286

 

Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397

 

 

 

 

 

N 1

 

FDA

 

Vol #:

 

1

 

 

 

2003P-0307

 

ANDA suitability for a new strength of Wararin Sodium Tablets, USP 1.5mg

 

 

 

 

 

ACK 1

 

HFA-305 to Taro Pharmaceuticals

 

Vol #:

 

1

 

 

 

CP 1

 

Taro Pharmaceuticals

 

Vol #:

 

1

Attachment 1, 2

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