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22005N-0010:
HIGH CHEMICAL CO. ET AL.; PROPOSAL TO WITHDRAW APPROVAL OF 13 NEW
DRUG APPLICATIONS; OPPORTUNITY FOR A HEARING
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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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| NPH1
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| 01/27/2005
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| FDA
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| FDA
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| 01/28/2005
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| 4134-4135
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| 02/28/2005
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| pdf
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| hearing
due 2/28/05supporting request 03/29/05
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| Signature:
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| SHUREN, JEFFREY
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| LET1
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| 02/02/2005
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| 02/01/2005
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| Drug Industry
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| Kendall Healthcare
Products
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| pdf
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| Signature:
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| Bridget Gardner
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| LET2
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| 03/02/2005
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| 02/25/2005
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| Drug Industry
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| Bayer HealthCare,
LLC
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| pdf
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| Signature:
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| Carol M. Moore
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| NWL1
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| 04/27/2005
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| FDA
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| FDA
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| 04/28/2005
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| 22054-22054
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| pdf
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| Signature:
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| Jeffrey Shuren
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| LET3
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| 04/29/2005
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| 04/29/2005
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| Federal
Government
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| HFA-305 to High
Chemical Co.
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| pdf
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| Signature:
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| Gloria Ortega
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Page last updated
May 10, 2005
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