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2004P-0051: Requests that the Commissioner of Food and Drug Admination Determine that Astra Zenecal LP's Dyclone(dyclonine hydrochloride) Topical Solution 0.5% and 1.0%(NDA 9-925) was Voluntarily withdrawn or withheld from sale for Reasons Other than Safety or Efficacy
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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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| 02/04/2004
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| 02/09/2004
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| Private
Industry
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| Arent Fox,Kintner
Plotkin & Kahn PLLC
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| pdf
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| Signature:
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| Wayne H. Matelski
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| ACK1
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| 02/09/2004
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| 02/09/2004
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| Federal
Government
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| HFA-305 to
Arent Fox Kintner Plotkin & Kahn PLLC
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| LET1
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| 07/30/2004
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| 07/30/2004
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| Federal
Government
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| HFD-005 to Arent Fox,
PLLC
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| pdf
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| Signature:
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| Jane A. Axelrad
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| N1
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| 11/15/2004
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| FDA
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| FDA
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| 11/16/2004
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| 67147-67148
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| pdf
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| Signature:
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| Jeffrey Shuren
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| LET2
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| 11/18/2004
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| 11/18/2004
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| Federal
Government
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| HFD-007 to Arent Fox,
PLLC
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| pdf
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| Signature:
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| Mary Catchings
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Top | Up
Page last updated:
August 24, 2007
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