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2007P-0116: Stay any Additional Abbreviated New Drug Applications for Generic Amlodipine Products until after the Mylan Pharmaceuticals Inc. 180-day Exclusivity Expires on September 23, 2007

Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
PSA1 03/26/2007 03/26/2007 Private Industry Mylan Pharmaceuticals Inc.       Table of Contents  
Signature: David J. Harth
ACK1 03/26/2007 03/26/2007 Federal Government FDA/DDM to Heller Ehrmann LLP       pdf  
Signature: Lyle D. Jaffe
EMC1 04/04/2007 04/04/2007 Private Industry Medco Health Solutions, Inc.       pdf CF 2007P-0110/EMC1, 2007P-0111/EMC1 and 2007N-0123
Signature: David S. Machlowitz  
EC1 04/05/2007 04/04/2007 Private Industry Heller Ehrman LLP       pdf  
Signature: Harth, David
C1 04/04/2007 04/04/2007 Private Industry Mutual Pharmaceutical Co. Inc.       Table of Contents  
Signature: John Will Ongman
C2 04/06/2007 04/06/2007 Private Industry Apotex Inc. (formerly TorPharm)       pdf  
Signature: Arthur Y Tsien
EMC2 04/10/2007 04/10/2007 Private Industry Synthon Pharmaceuticals, Inc.       pdf  
Signature: Michael H. Hinckle

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Page last updated: April 17, 2007