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2003P-0365:GALDERMA
PRODUCT, SOLAGE CONTAINING 2% MEQUINOL, AND 0.01% TRETINOIN, NDA
20-922 CAN BE FORMULATED AS A TOPICAL SOLUTION WITH THE SUBSTITUTION
OF HYDROQUINONE AT 4% FOR THE 2% MEQUINOL AS AN ANDA
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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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| 08/12/2003
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| 08/13/2003
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| Private
Industry
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| Jerussi
Consulting, Inc.
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| pdf,
Copyrighted
Material
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| Signature:
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| Robert A. Jerussi,
Ph.D.
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| ACK1
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| 08/13/2003
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| 08/13/2003
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| Federal
Government
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| HFA-305
to Jerussi Consulting, Inc.
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| pdf,
doc
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| Signature:
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| Lyle D. Jaffe
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| C1
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| 11/14/2003
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| 11/14/2003
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| Drug Industry
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| Galderma
Laboratories
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| pdf
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| Signature:
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| Paul Clark
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| C2
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| 01/16/2004
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| 01/16/2004
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| Private
Industry
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| Jerussi
Consulting, Inc.
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| pdf
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| Signature:
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| Robert A. Jerussi,
PhD
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| LET1
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| 02/05/2004
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| 02/05/2004
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| Federal
Government
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| HFD-600
to Jerussi Consulting Inc
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| pdf
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| Signature:
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| Gary Buehler
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| LET2
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| 03/30/2004
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| 03/30/2004
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| Private
Industry
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| Jerussi
Consulting, Inc.
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| pdf
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| Signature:
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| Robert A. Jerussi,
PhD
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| PDN1
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| 10/19/2004
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| 10/19/2004
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| Federal
Government
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| HFD-600
to Jerussi Consulting, Inc.
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| pdf
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| Signature:
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| Gary J. Buehler
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| LET3
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| 11/12/2004
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| 11/12/2004
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| Private
Industry
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| Jerussi
Consulting, Inc.
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| pdf
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| Signature:
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| Robert A. Jerussi,
PhD
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| PDN2
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| 12/03/2004
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| 12/03/2004
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| Federal
Government
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| HFD-600
to Jerussi Consulting, Inc.
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| pdf
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| Signature:
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| Gary J. Buehler
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Top | Up
Page last updated
December 30, 2004
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