| Up
2006P-0123:
Request that all Applicants for Fentanyl Transdermal
Systems Conduct a Study to Support the Safety of their Fentanyl
Transdermal Products
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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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| ACK1
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| 03/17/2006
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| 03/17/2006
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| Federal Government
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| HFA-305 to Mylan Laboratories
Inc.
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| pdf
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| Signature:
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| Jennie C. Butler
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| CP1
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| 03/17/2006
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| 03/17/2006
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| Private Industry
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| Mylan Laboratories
Inc.
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| pdf
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| Signature:
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| John P. O'Donnell
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| SUP1
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| 03/22/2006
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| 03/22/2006
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| Private Industry
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| Mylan Laboratories
Inc.
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| Table
of Contents
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| Signature:
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| John P.O'Donnell
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| C1
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| 04/28/2006
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| 04/24/2006
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| Health Professional
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| D. Lowe
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| C2
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| 05/02/2006
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| 04/27/2006
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| Individual Consumer
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| D. Lowe
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| SUP2
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| 05/26/2006
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| 05/26/2006
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| Drug Industry
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| Mylan Laboratories
Inc.
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| pdf
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| Signature:
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| John P. O'Donnell
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| C3
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| 05/31/2006
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| 05/25/2006
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| Individual Consumer
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| D. Lowe
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| C4
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| 07/20/2006
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| 07/18/2006
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| Drug Industry
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| PriCara, Unit of Ortho-McNeil
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| pdf
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| Signature:
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| Bruce L. Moskovitz, MD
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| SUP3
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| 08/10/2006
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| 08/09/2006
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| Private Industry
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| Mylan Laboratories
Inc.
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| pdf
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| Signature:
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| John O'Donnell, PhD
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LET1 |
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09/12/2006
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09/12/2006
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|
Federal Government |
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FDA/CDER to
Mylan Laboratories Inc. |
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pdf |
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Signature: |
|
Jane A. Axelrad |
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| SUP4
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| 11/13/2006
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| 11/10/2006
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| Drug Industry
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| Mylan Laboratories
Inc.
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| pdf
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| Signature:
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| John P. O'Donnell
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| PSA1
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| 07/24/2007
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| 07/24/2007
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| Private Industry
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| Mylan Technologies
Inc.
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| pdf
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| Signature:
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| Carolyn Myers, Ph.D.
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| ACK2
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| 07/25/2007
|
| 07/25/2007
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| Federal Government
|
| FDA/DDM to Mylan Technologies
Inc.
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| pdf
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| Signature:
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| Lyle D. Jaffe
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Top | Up
Page last updated
August 22, 2007
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