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1980N-0208: BIOLOGICAL PRODUCTS; BACTERIAL VACCINES AND TOXIODS
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
BKG1 12/12/1985 12/12/1985 Legacy BACKGROUND          
Signature: BACKGROUND
BKG2 12/12/1985 12/12/1985 Federal Government
 BACKGROUND         BER NUMBERS 2001 THROUGH 2124
Signature: BACKGROUND
NPR1   12/12/1985 FDA FDA     03/13/1986    
Signature: FDA
C1 01/14/1986 01/09/1986 Private Industry ARMOUR PHARM CO          
Signature: ARMOUR PHARM CO
M1 01/24/1986 01/24/1986 Other Organization HFN-364          
Signature: S Falter
C2 03/14/1986 03/13/1986 Private Industry CUTTER LABS MILES LABS INC          
Signature: CUTTER LABS MILES LABS INC
NCR1   03/25/1986 FDA FDA          
Signature: FDA
C3 04/14/1986 04/11/1986 Private Industry LEDERLE LAB          
Signature: LEDERLE LAB
C4 04/28/1986 04/24/1986 Other Organization CASE WESTERN RESERVE U          
Signature: CASE WESTERN RESERVE U
NPH1   04/06/1987 FDA FDA     06/08/1987    
Signature: FDA
HER1 04/22/1987 04/20/1987 Other Organization ST OF MI DEPT OF PUB HLTH          
Signature: ST OF MI DEPT OF PUB HLTH
BKG3 12/30/2003 12/30/2003 Federal Government
 Background Material          
Signature: Background Material
NFR1   12/30/2003 FDA FDA 01/05/2004 255-267   pdf Effective Jamuary 4, 2005
Signature: SHUREN, JEFFREY
NCR2   02/12/2004 FDA FDA 02/13/2004 7114-7115   pdf Effective 02/13/04
Signature: SHUREN, JEFFREY
REF1 03/15/2004 03/15/2004 Federal Government
 References          
Signature: Kathleen Swisher
RPT1 12/20/2004 12/20/2004 Federal Government
 Panel Report on Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
       pdf  
Signature: Panel Report on Bacterial Vaccines a
NWL1   12/23/2004 FDA FDA 12/29/2004 78280-78280   pdf Withdrawal for NFR of 1/4/04 69FR255
Signature: SHUREN, JEFFREY
BKG5 12/29/2004 12/29/2004 Federal Government
 Background Information for Notice of Withdrawal of 12/29/04
       Table of Contents  
Signature: Background Information for Notice of

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