| Up
2005P-0360:
FDA Should Not Approve ANDA or NDA Under 505(b)(2) ('505(b)(2) NDAs)
for Salmon Calcitonin Products Unless Certain Conditions Are Met
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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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| 09/02/2005
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| 09/06/2005
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| Private Industry
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| Foley & Lardner
LLP
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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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| ACK1
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| 09/06/2005
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| 09/06/2005
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| Federal Government
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| HFA-305 to Foley &
Lardner LLP
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| C1
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| 09/14/2005
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| 09/13/2005
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| Drug Industry
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| Novartis Pharmaceuticals
Corporation
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| pdf
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| Signature:
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| Roxanne Tavakkol
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| C2
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| 10/14/2005
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| 10/13/2005
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| Drug Industry
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| Nastech Pharmaceutical
Company, Inc. (Nastech)
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| pdf
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| Signature:
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| Gordon Brandt, M.D.
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| LET1
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| 03/07/2006
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| 03/07/2006
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| Federal Government
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| HFD-005 to Foley &
Lardner LLP
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| pdf
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| Signature:
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| HFD-005 to Foley & Lardner
LLP
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| RC1
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| 03/16/2006
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| 03/15/2006
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| Private Industry
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| Foley & Lardner
LLP
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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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Top | Up
Page last updated
May 4, 2006
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