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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
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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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| PSA1
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| 03/26/2007
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| 03/26/2007
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| Private Industry
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| Mylan Pharmaceuticals
Inc.
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| Table
of Contents
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| Signature:
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| David J. Harth
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| ACK1
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| 03/26/2007
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| 03/26/2007
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| Federal Government
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| FDA/DDM to Heller
Ehrmann LLP
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| EMC1
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| 04/04/2007
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| 04/04/2007
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| Private Industry
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| Medco Health Solutions,
Inc.
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| pdf
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| CF 2007P-0110/EMC1,
2007P-0111/EMC1 and 2007N-0123
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| Signature:
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| David S. Machlowitz
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| EC1
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| 04/05/2007
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| 04/04/2007
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| Private Industry
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| Heller Ehrman LLP
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| pdf
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| Signature:
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| Harth, David
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| C1
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| 04/04/2007
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| 04/04/2007
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| Private Industry
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| Mutual Pharmaceutical
Co. Inc.
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| Table
of Contents
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| Signature:
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| John Will Ongman
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| C2
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| 04/06/2007
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| 04/06/2007
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| Private Industry
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| Apotex Inc. (formerly
TorPharm)
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| pdf
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| Signature:
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| Arthur Y Tsien
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| EMC2
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| 04/10/2007
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| 04/10/2007
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| Private Industry
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| Synthon Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Michael H. Hinckle
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Top
| Up
Page last updated:
April 17, 2007
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