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1998D-0514:
Industry on ANDA's: Impurities in Drug Substances
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| GDL1
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| 07/23/1998
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| 07/30/1998
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| Legacy
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| HFD-625
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| Signature:
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| HFD-625
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| NAD1
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| 07/23/1998
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| FDA
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| FDA
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| 09/22/1998
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| AVAILABLE
FROM HFD-210
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| Signature:
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| FDA
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| EXT1
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| 08/04/1998
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| 08/03/1998
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| Private Industry
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| Perrigo Co.
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| pdf
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| Signature:
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| David A. Jespersen
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| EXT2
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| 08/10/1998
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| 08/04/1998
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| Association
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| Nat. Assn. of Pharmaceutical
Mfrs.
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| pdf
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| Signature:
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| Leon Shargel Ph.D.
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| EXT3
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| 09/04/1998
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| 09/04/1998
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| Association
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| GPIA
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| pdf
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| Signature:
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| Alice E. Till Ph.D.
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| C1
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| 09/22/1998
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| 09/22/1998
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| Association
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| NPA National Pharmaceuitcal
Alliance
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| pdf
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| Signature:
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| Christina Sizemore by R Jerussi
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| C2
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| 09/22/1998
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| 09/22/1998
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| Private Industry
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| Glaxo Wellcome Research
& Development
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| pdf
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| Signature:
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| Suva B. Roy, Ph.D.
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| C3
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| 09/25/1998
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| 09/24/1998
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| Association
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| GPIA
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| pdf
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| Signature:
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| Alice E. Till, Ph.D.
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| NEC1
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| 10/16/1998
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| FDA
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| FDA
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| 11/23/1998
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| pdf
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| Signature:
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| FDA
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| C4
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| 11/23/1998
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| 11/23/1998
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| Private Industry
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| Apotex Corp.
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| pdf
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| Signature:
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| Marcy Macdonald
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| C5
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| 11/23/1998
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| 11/18/1998
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| Private Industry
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| Paul G. King Consulting
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| pdf
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| Signature:
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| Paul G. King, Ph.D.
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| C6
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| 12/10/1998
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| 12/04/1998
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| Private Industry
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| Merck & Co., Inc.
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| pdf
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| Signature:
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| Bonnie J. Goldmann, M.D.
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| C7
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| 01/05/1999
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| 12/28/1998
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| Association
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| National Assn. of
Pharmaceutical Manufac
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| pdf
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| Signature:
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| Leon Shargel, Ph.D.
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| GDL2
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| 12/03/1999
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| 12/07/1999
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| Legacy
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD2
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| 12/02/1999
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| FDA
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| FDA
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| 12/03/1999
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| 67917-67918
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| pdf
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| Signature:
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| DOTZEL, MARGARET
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| GDL3
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| 01/28/2005
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| 01/28/2005
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| Federal
Government
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| Guidance
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| pdf
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| Signature:
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| Guidance
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| NAD3
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| 01/28/2005
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| FDA
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| FDA
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| 01/31/2005
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| 4857-4857
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| 05/02/2005
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| pdf
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| Signature:
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| Jeffrery Shuren
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| EC1
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| 04/13/2005
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| 04/07/2005
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| Drug Industry
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| Teva Pharmaceutical
Industries Ltd.
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| pdf
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| Signature:
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| Rotem, Nava
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| C8
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| 04/20/2005
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| 04/19/2005
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| Drug Industry
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| Sanofi-Synthelabo, Inc. and Aventis Pharmaceuticals (Sanofi Aventis)
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| pdf
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| Signature:
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| Steve Caffe, MD
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Page last updated
October 3, 2005
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