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1998D-0514: Industry on ANDA's: Impurities in Drug Substances

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
GDL1 07/23/1998 07/30/1998 Legacy HFD-625          
Signature: HFD-625
NAD1   07/23/1998 FDA FDA     09/22/1998   AVAILABLE FROM HFD-210
Signature: FDA
EXT1 08/04/1998 08/03/1998 Private Industry Perrigo Co.       pdf  
Signature: David A. Jespersen
EXT2 08/10/1998 08/04/1998 Association Nat. Assn. of Pharmaceutical Mfrs.       pdf  
Signature: Leon Shargel Ph.D.
EXT3 09/04/1998 09/04/1998 Association GPIA       pdf  
Signature: Alice E. Till Ph.D.
C1 09/22/1998 09/22/1998 Association NPA National Pharmaceuitcal Alliance       pdf  
Signature: Christina Sizemore by R Jerussi
C2 09/22/1998 09/22/1998 Private Industry Glaxo Wellcome Research & Development       pdf  
Signature: Suva B. Roy, Ph.D.
C3 09/25/1998 09/24/1998 Association GPIA       pdf  
Signature: Alice E. Till, Ph.D.
NEC1   10/16/1998 FDA FDA     11/23/1998 pdf  
Signature: FDA
C4 11/23/1998 11/23/1998 Private Industry Apotex Corp.       pdf  
Signature: Marcy Macdonald
C5 11/23/1998 11/18/1998 Private Industry Paul G. King Consulting       pdf  
Signature: Paul G. King, Ph.D.
C6 12/10/1998 12/04/1998 Private Industry Merck & Co., Inc.       pdf  
Signature: Bonnie J. Goldmann, M.D.
C7 01/05/1999 12/28/1998 Association National Assn. of Pharmaceutical Manufac       pdf  
Signature: Leon Shargel, Ph.D.
GDL2 12/03/1999 12/07/1999 Legacy Guidance       pdf  
Signature: Guidance
NAD2   12/02/1999 FDA FDA 12/03/1999 67917-67918   pdf  
GDL3 01/28/2005 01/28/2005 Federal Government
Guidance       pdf  
Signature: Guidance
NAD3   01/28/2005 FDA FDA 01/31/2005 4857-4857 05/02/2005 pdf  
Signature: Jeffrery Shuren
EC1 04/13/2005 04/07/2005 Drug Industry Teva Pharmaceutical Industries Ltd.       pdf  
Signature: Rotem, Nava
C8 04/20/2005 04/19/2005 Drug Industry Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals (Sanofi Aventis)
Signature: Steve Caffe, MD

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