Dockets Management

Dockets Entered On August 6, 2003

Docket #

Title

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

1996N-0417. 1    CGMP in Mfg. Packing or Holding Dietary Supplements. 1

1997N-0497. 1     Allogeneic Peripheral and Placental/ Umbilical Cord Blood. 1

2000F-0792. 1     OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT  1

2000N-1484. 1     Safety Reporting Requirements Human Drug/Biological Products. 1

2002N-0276. 1     Bioterrorism Preparedness; Registration of Food Facilities. 1

2002P-0349. 1     Amend product insert and/or label for Hemophilus Vaccines. 1

2003D-0353. 1     Guidance for Industry & FDA. 1

2003N-0168. 1     July 31, 2003 Public Meeting on Consumer Medication Information. 1

2003P-0029. 2     Remove metered-dose inhalers (MDI) containing moiety albuter 2

2003P-0064. 2     Withhold Approval of Generic Lovenox (enoxaparin sodium inje. 2

2003P-0091. 2     ANDA to declare that drug prod Hydrocodone Polistirex & Chlo. 2

2003P-0275. 2     Reclassify Cyclosporine (CSA) as Non-antibiotic Drug. 2

2003P-0313. 2     Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing  2

1975N-0183H

Health-Care Antiseptic Drug Products for OTC Human Use

C 62

American Journal of Infection Control (AJIC)

Vol #:

149

1996N-0417

CGMP in Mfg. Packing or Holding Dietary Supplements

C 135

Bioiberica (Barcelona)

Vol #:

21

EXT 7

Utah Natural Products Alliance

Vol #:

21

EXT 8

American Herbal Products Assn (AHPA)

Vol #:

21

M 2

Number not used

Vol #:

21

1997N-0497

Allogeneic Peripheral and Placental/ Umbilical Cord Blood

M 1

HFM-755

Vol #:

6

Attachment

2000F-0792

OLESTRA BE AMENDED REMOVING REQUIREMENT FOR LABEL STATEMENT

BKG 2

Background Material

Vol #:

12

Tab 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43

NFR 1

FDA

Vol #:

11

2000N-1484

Safety Reporting Requirements Human Drug/Biological Products

C 3

Dartmouth Hitchcock Medical Center

Vol #:

3

2002N-0276

Bioterrorism Preparedness; Registration of Food Facilities

MM 14

HFS-32

Vol #:

13

2002P-0349

Amend product insert and/or label for Hemophilus Vaccines

SUP 3

Clasen Immunotherapies, Inc.

Vol #:

2

Attachment

2003D-0353

Guidance for Industry & FDA

GDL 1

AACC, Advancing Clinical Laboratory Science World

Vol #:

1

2003N-0168

July 31, 2003 Public Meeting on Consumer Medication Information

C 2

Public Citizen's Health research Group

Vol #:

2

C 3

Center for Medical Consumers

Vol #:

2

C 4

American Society of Health-System Pharmacists

Vol #:

2

C 5

Pharmacists Planning service, Inc.

Vol #:

2

LST 2

Attendance Record Public Meeting (Consumer Medication Information) 7/31/2003

Vol #:

2

S 1

HF-1

Vol #:

2

TS 2

AARP

Vol #:

2

TS 3

Thomson Healthcare, Inc.

Vol #:

2

TS 4

Pharmaceutical Printed Literature Assn (PPLA)

Vol #:

2

TS 5

Pharmaceutical Research and Manufacturers of America

Vol #:

2

TS 6

National Council on Patient Information and Education (NCPIE)

Vol #:

2

TS 7

NCPIE

Vol #:

2

TS 8

NCPIE

Vol #:

2

TS 9

NCPIE

Vol #:

2

TS 10

NCPIE

Vol #:

2

TS 11

NCPIE

Vol #:

2

TS 12

Cerner Multum

Vol #:

2

TS 13

Pharmaceutical Printed Literature Assn (PPLA)

Vol #:

2

TS 14

ScriptChek Visual Verification Systems, Inc.

Vol #:

2

TS 15

NACDS

Vol #:

2

TS 16

University of Wisconsin

Vol #:

2

TS 17

Paul J. Seligman, MD,MPH & Tom McGinnis, R.Ph

Vol #:

2

2003P-0029

Remove metered-dose inhalers (MDI) containing moiety albuter

SUP 1

GlaxoSmithKline

Vol #:

1

2003P-0064

Withhold Approval of Generic Lovenox (enoxaparin sodium inje

LET 1

HFD-5 to Covington & Burling

Vol #:

3

2003P-0091

ANDA to declare that drug prod Hydrocodone Polistirex & Chlo

RC 1

Lachman Consultant Services, Inc.

Vol #:

1

2003P-0275

Reclassify Cyclosporine (CSA) as Non-antibiotic Drug

ACK 2

HFA-305 to Allergan, Inc.

Vol #:

1

PSA 1

Allergan, Inc.

Vol #:

1

Tab A, B, C, D, E, F, G, H, I, J, K

SUP 1

Allergan, Inc.

Vol #:

1

2003P-0313

Canned Tuna Deviating From Identity Standard; Temporary Permit for Market Testing

NTF 1

Number not used

Vol #:

1

NTP 1

FDA

Vol #:

1