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2004P-0523:
Ensure that Proposed Generic Nasal Spray Products Meet the Same
High Standards of Quality as GSK's Brand-name Product, Flonase(fluticasone
propinate)Nasal Spray, 50 mcg
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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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| 11/23/2004
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| 11/24/2004
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| Drug Industry
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| GlaxoSmith Kline
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| pdf
TabB
TabC
TabD
Copy-
righted
Material
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| Signature:
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| Dr. Elaine Jones,Mr. William
M. Zoffer
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| ACK1
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| 11/24/2004
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| 11/24/2004
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| Federal Government
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| HFA-305 to GlaxoSmith
Kline
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| pdf,
doc
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| Signature:
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| Jennie Butler
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| SUP1
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| 12/02/2004
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| 12/02/2004
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| Drug Industry
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| GlaxoSmithKline (GSK)
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| pdf
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| Signature:
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| Brian R. McCormick
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| PSA1
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| 03/25/2005
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| 03/25/2005
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| Private Industry
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| GlaxoSmithKline
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| pdf
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| Signature:
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| C. Elaine Jones Ph.D.
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| ACK2
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| 03/31/2005
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| 03/31/2005
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| Federal Government
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| HFA-305 toGlaxoSmithKline
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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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| 05/20/2005
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| 05/20/2005
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| Federal Government
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| HFD-005 to GlaxoSmithKline
(GSK)
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| pdf
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| Signature:
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| Jane A. Axelrad
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| PDN1
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| 02/22/2006
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| 02/22/2006
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| Federal Government
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| FDA/OPP to McGuire
Woods LLP, GlaxoSmithKline, Frommer Lawrence & Haug LLP
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| pdf
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| Signature:
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| Randall W Lutter, PhD
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| REF1
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| 03/02/2006
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| 03/02/2006
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| Federal Government
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| References
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| Table
of Contents
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| C1
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| 05/25/2006
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| 05/23/2006
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| Individual Consumer
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| D. Lowe
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Top
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Page last updated:
August 7, 2007
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