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2004P-0015:
DENY APPROVAL OF ANY NEW DRUG APPLICATION ( NDA ) FOR RECOMBINANT
SALMON CALCITONIN (RSCT ) NASAL SPRAY
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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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| 01/09/2004
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| 01/09/2004
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| Drug Industry
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| Buc & Beardsley
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| pdf
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| Signature:
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| Nancy L. Buc
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| ACK1
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| 01/09/2004
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| 01/09/2004
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| Government
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| HFA-305 to Buc &
Beardsley
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| doc
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| Signature:
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| Jennie C. Butler
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| LET1
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| 07/08/2004
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| 07/08/2004
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| Federal
Government
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| HFD-005 to Buc &
Beardsley
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| pdf
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| Signature:
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| Jane A. Axelrad
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| EMC1
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| 01/25/2005
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| 01/25/2005
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| Private Industry
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| Investor in Unigene,
Inc.
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| Signature:
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| Douglas Goble
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| EMC2
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| 04/11/2005
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| 04/11/2005
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| Drug Industry
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| Unigene Laboratories,
Inc. (Unigene)
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| 01,
02
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| Signature:
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| Ronald S. Levy, PhD
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| RC1
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| 04/27/2005
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| 04/27/2005
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| Private Industry
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| Buc & Beardsley
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| pdf
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| Signature:
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| Nancy L. Buc
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| PDN1
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| 08/16/2005
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| 08/16/2005
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| Federal Government
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| HFD-001 to Buc &
Beardsley
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| pdf
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| Signature:
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| Steven K. Galson, MD, MPH
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Top
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Page last updated
October 12, 2005
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