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2005N-0403: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
NPR1   08/23/2006 FDA FDA 08/29/2006 51276-51357 11/27/2006 htm pdf  
Signature: Jeffrey Shuren
BKG1 08/23/2006 08/23/2006 Federal Government
Background Material       Table of Contents  
EMC1 08/29/2006 08/29/2006 Individual Consumer J. Benner        
EMC2 08/31/2006 08/31/2006 Individual Consumer P. Carr        
REF1 09/05/2006 09/05/2006 Federal Government
OMB Review       Part 1
Part 2
Part 3
EC1 09/26/2006 09/25/2006 Association Compressed Gas Association       pdf  
Signature: Meteyer, Marc
EC2 09/27/2006 09/26/2006 Drug Association Animal Health Institute       pdf  
Signature: Palla, Madeline
C1 10/05/2006 10/03/2006 Drug Industry Novartis Pharmaceuticals Corporation       pdf  
Signature: Soraya Madani, PhD
EXT1 10/12/2006 10/12/2006 Health Care Association
Consumer Healthcare Products Association (CHPA)
Signature: Paul J. Larsen, Esq
EXT2 10/16/2006 10/13/2006 Drug Industry L. Perrigo Company (Perrigo)       pdf  
Signature: Heidi Horn
NEC1   10/30/2006 FDA FDA 10/31/2006 63726-63728 01/26/2007 htm
Meeting on 12/11/2006
Signature: Jeffrey Shuren
C2 11/15/2006 11/07/2006 Association Allergen Products Maufacturers Association       pdf  
Signature: Rebecca R. Johnson, DPh
EMC3 11/17/2006 11/16/2006 Drug Industry Becton, Dickinson & Company       txt  
Signature: Jing Zhang
C3 11/20/2006 11/20/2006 Drug Industry Tap Pharmaceutical Products, Inc.       pdf  
Signature: Jean M. Conaway, R.Ph., RAC, MBA
C4 11/24/2006 11/24/2006 Private Industry GE Health Care       pdf  
Signature: Fred Longenecker
EC3 11/27/2006 11/22/2006 Drug Industry Ben Venue Laboratories, Inc.       htm  
Signature: Richesson, C
EC4 11/27/2006 11/24/2006 Drug Industry Genpharm Inc       pdf  
Signature: Kumar, Salendar
EC5 11/27/2006 11/24/2006 Drug Association Generic Pharmaceutical Association       htm  
Signature: Johnston, Gordon
EC6 11/27/2006 11/24/2006 Drug Industry Taro Pharmaceuticals USA Inc.       htm  
Signature: Tung, Teresa
C5 11/21/2006 11/21/2006 Drug Industry TAP Pharmaceutical Products, Inc.       pdf  
Signature: Jean M. Conaway, R.Ph., RAC, MBA
C6 11/21/2006 11/21/2006 Drug Industry Ranbaxy, Inc.       pdf  
Signature: Adina Tortu
C7 11/27/2006 11/22/2006 Drug Industry Nelco Laboratories, Inc.       pdf  
Signature: April Catanzaro
C8 11/28/2006 11/28/2006 Association National Association of Foreign-Trade Zones       pdf  
Signature: Ray E. Shaw
EMC4 11/28/2006 11/27/2006 Internationalal Government
China       txt
Signature: Guo LiSheng
EC7 12/01/2006 11/30/2006 Private Industry QA       htm  
EC8 12/01/2006 11/30/2006 Drug Industry Ben Venue Laboratories, Inc.       htm  
Signature: Benyo, Laurel
C9 12/01/2006 12/01/2006 Private Industry HollisterStier Laboratories LLC       pdf  
Signature: David L Mirabell
EC9 12/07/2006 12/06/2006 Drug Industry Anabolic Laboratories, Inc.       htm  
Signature: van Osdel, Bob
C10 12/11/2006 12/06/2006 Health Care Association
National Council for prescription Drug Programs (NCPDP)
Signature: Lee Ann C. Stember
EC10 12/18/2006 12/15/2006 Drug Association NDC Working Group       htm  
Signature: Wallace, Robert
EREG1 12/19/2006 12/18/2006 Federal Government
National Committee on Vital & Health Statistics       pdf  
Signature: Simon Cohn
C11 01/03/2007 01/03/2007 Health Care Association
Mount Sinai Hospital       pdf  
Signature: Yelena Sinitsyn, MS
C12 01/03/2007 12/29/2006 Drug Industry Greer Laboratories, Inc.       pdf  
Signature: Larry Tamura
C13 01/08/2007 01/03/2007 Drug Industry Roxane Laboratories, Inc.       pdf  
Signature: Elizabeth Ernst
TR1 01/12/2007 01/12/2007 Federal Government Transcript of December 11, 2006 Public Meeting       pdf  
TS1 01/12/2007 01/12/2007 Federal Government
FDA/CDER       htm
FDA's Proposed Revised 21CFR207 Rule and Electronic Drug Registration and Listing Systems (e-DRLS)
Signature: John W Gardner MD DrPH
TS2 01/12/2007 01/12/2007 Private Industry Hospira Inc       htm
The Proposed Changes to NDA System, Legacy NDC Numbers and Compliance
Signature: Dr Thomas F Willer
TS3 01/12/2007 01/12/2007 Private Industry Perrigo       htm
Signature: Heidi Horn
TS4 01/12/2007 01/12/2007 Association CHPA       htm
Signature: Paul J Larsen, Esq.
TS5 01/12/2007 01/12/2007 Association ICCBBA       htm
Use of ISBT 128 in the Labeling of Cellular Therapy Products
Signature: Pat Distler
TS6 01/12/2007 01/12/2007 Private Industry AABB`       htm
National Drug Codes for HCT/Ps
Signature: M Allene Carr-Greer, MT ASCP(SBB)

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Page last updated: February 12, 2007