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2003P-0366:
AMEND APPROVAL FOR A NONPRESCRIPTION FORM OF PRILOSEC (OMEPRAZOLE
MAGNESIUM)
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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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| Mattingly,
Stanger & Malur, P.C.
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| pdf
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| Signature:
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| John R. Mattingly
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| ACK1
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| 08/14/2003
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| 08/14/2003
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| Federal
Government
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| HFA-305
to Mattingly, Stanger & Malur, P.C.
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| doc
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| Signature:
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| John R. Mattingly
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| C1
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| 09/29/2003
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| 09/29/2003
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| Private
Industry
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| Covington
& Burling
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| pdf
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| Signature:
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| Peter O. Safir
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| LET1
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| 10/16/2003
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| 10/16/2003
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| Drug Industry
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| Mylan Pharmaceuticals,
Inc.
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| pdf
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| Signature:
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| Stuart A. Williams
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| SUP1
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| 12/16/2003
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| 12/16/2003
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| Drug Industry
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| Mylan Pharmaceuticals,
Inc.
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| 1pdf,
2pdf,
summary-report,
pharmacokinetic-report,
concentration-vs-time-data-table,
pharmacokinnetic-parameter-table,
concentration-vs-time-plots,
pharmacokinetic-data-analysis01,
pharmacokinetic-data-analysis-02,
statistical-analysis-text-output,
method-valid-action-report,
bioanalytical-report,
sample-analysis-table,
protocol,
reference-standard-cert,
raw-data
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| Signature:
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| Russ Rackley, PhD
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| C2
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| 12/12/2003
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| 12/11/2003
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| Drug Industry
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| Mylan Pharmaceuticals,
Inc. (Mylan)
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| pdf,
Exhibits: Fpdf,
Gpdf
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| Signature:
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| Stuart A. Williams
& John O'Donnell
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| SUP2
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| 12/12/2003
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| 12/12/2003
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| Drug Industry
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| Mylan Phamaceuticals,
Inc. (Mylan)
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| pdf,
CVs
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| Supplements
C2 found in this docket.
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| Signature:
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| Dawn J. Beto
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| LET2
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| 01/27/2004
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| 01/27/2004
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| Federal
Government
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| HFD-5 to
Mattingly, Stanger & Malur
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| pdf
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| Signature:
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| Jane A Axelrad
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| SUP3
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| 02/03/2004
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| 02/02/2004
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| Drug Industry
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| Mylan Phamaceuticals,
Inc. (Mylan)
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| pdf
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| Supplements
December 11, 2003 comment found in this docket.
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| Signature:
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| Stuart A. Williams
& John O'Donnell
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| C3
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| 04/01/2004
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| 03/29/2004
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| Drug Industry
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| The Procter
& Gamble Company (P&G)
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| pdf
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| Signature:
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| Paul Franz
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| C4
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| 11/01/2004
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| 10/28/2004
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| Drug Industry
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| Mylan Laboratories,
Inc.
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| pdf
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| Signature:
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| Stuart A. Williams
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| EMC1
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| 11/19/2004
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| 11/19/2004
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| Private
Industry
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| Procter
& Gamble
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| txt,
Attachment pdf, doc
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| Signature:
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| Paul Franz
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Top | Up
Page last updated
December 9, 2004
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