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2005P-0352: Require that Standard Bioequivalence Criteria be Applied Separately to Oxybutynin and its Active Metabolite, Desethyloxbutynin, to Ensure that Approved Generic Versions of DITROPAN XL are both Equivalent and Clinicaly Equivalent to the Innovator Product
Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
CP1 08/29/2005 08/30/2005 Drug Industry Ortho-McNeil Pharmaceutical, Inc.       Table of Contents  
Signature: Minnie Baylor-Henry
ACK1 08/30/2005 08/30/2005 Drug Industry HFA-305 to Ortho-McNeil Pharmaceutical, Inc.       pdf  
Signature: Lyle D. Jaffe
C1 10/03/2005 09/30/2005 Drug Industry Mylan Pharmaceuticals, Inc.       pdf  
Signature: Russell J. Rackley, PhD
SUP1 10/07/2005 10/07/2005 Drug Industry Ortho-McNeil Pharmaceutical, Inc.       Table of Contents  
Signature: Minnie Baylor-Henry
C2 11/14/2005 11/11/2005 Drug Industry Mylan Pharmaceuticals, Inc.       pdf  
Signature: Russell J. Rackley, PhD
C3 11/23/2005 11/21/2005 Drug Industry IMPAX Laboratories Inc       pdf  
Signature: Mark C Shaw
EC1 01/11/2006 01/09/2006 Individual Consumer Mr. Dave Lowe       htm
Attachment 		 
EC2 02/01/2006 01/21/2006 Individual Consumer Mr. Dave Lowe       htm  
LET1 03/02/2006 03/02/2006 Federal Government FDA/CDER to Ortho-McNeil Pharmaceutical, Inc.       pdf  
  Signature: Jane A. Axelrad
PAV1 11/14/2006 11/14/2006 Federal Government FDA/CDER to Ortho-McNeil Pharmaceutical, Inc.       pdf  
  Signature: Steven K. Galson, M.D., M.P.H.

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Page last updated November 21, 2006 kkhorizonal rule
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