| Up
2004P-0339:
Refuse to file Abbreviated New Drug Application (ANDA) for the Combination
Drug Amlodipine Besylate-benazepril Hydrochloride (amlodipine-benazepril)
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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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| CP1
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| 07/29/2004
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| 07/29/2004
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| Private Industry
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| Fommer Lawrence &
Haug LLP
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| pdf
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| Signature:
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| Charles J. Raubicheck
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| ACK1
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| 07/29/2004
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| 07/29/2004
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| Federal Government
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| HFA-305 to Fommer
Lawrence & Haug LLP
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| pdf
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| Signature:
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| Jennie C. Butler
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| C1
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| 12/03/2004
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| 12/02/2004
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| Private Industry
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| Dr. Reddy's Laboratories
(Dr. Reddy's)
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| pdf
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| Signature:
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| David L. Rosen, B.S. Pharm.,
J.D.
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| LET1
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| 01/25/2005
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| 01/25/2005
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| Federal Government
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| HFD-005 to Frommer
Lawrence & Haug, LLP
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| pdf
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| Signature:
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| Jane A. Axelrad
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| PAV1
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| 07/13/2006
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| 07/13/2006
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| Federal Government
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| FDA/CDER to Fommer
Lawrence & Haug LLP
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| pdf
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| Signature:
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| Steven K. Galson, MD, MPH
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Page last updated
August 4, 2006
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