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2006P-0392:
Refrain from Approving any ANDA for a Diazepam Rectal Gel that Relies
on Diastat
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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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| 09/25/2006
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| 09/25/2006
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| Federal Government
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| FDA/DDM to Valeant
Pharmaceuticals International (Valeant)
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| pdf
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| Signature:
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| Gloria Ortega
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| CP1
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| 09/22/2006
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| 09/22/2006
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| Drug Industry
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| Valeant Pharmaceuticals
International (Valeant)
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| pdf
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| Signature:
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| Greg J. Kricorian, M.D.
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| EC1
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| 10/10/2006
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| 10/07/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| EC2
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| 10/10/2006
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| 10/08/2006
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| Individual Consumer
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| Mr. Dave Lowe
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| C1
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| 11/17/2006
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| 11/17/2006
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| Drug Industry
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| Valeant Pharmaceuticals
International (Valeant)
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| Table
of Contents
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| Signature:
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| Greg J. Krikorian, M.D.
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| EC3
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| 01/31/2007
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| 01/30/2007
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| Individual Consumer
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| Mr. Dave Lowe
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| LET1
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| 03/22/2007
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| 03/22/2007
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| Federal Government
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| FDA/CDER to Valeant
Pharmaceuticals International
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| pdf
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| Signature:
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| Jane A Axelrad
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| C2
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| 03/23/2007
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| 03/23/2007
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| Drug Industry
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| Valeant Pharmaceuticals
International
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| pdf
Cover Letter
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| Signature:
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| Greg J Kricorian MD,
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Top
| Up
Page last updated:
June 1, 2007
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