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2006P-0285:
Refrain from Granting any Bioequivalence Waiver for any ANDA Referencing
Duramed's NDA 21-544 for Seasonal
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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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| ACK1
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| 07/17/2006
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| 07/17/2006
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| Federal Government
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| FDA/DDM to Duramed
Research, Inc.
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| pdf
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| Signature:
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| Gloria Ortega
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| CP1
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| 07/14/2006
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| 07/14/2006
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| Private Industry
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| Duramed Research,
Inc.
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| pdf
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| Signature:
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| Joseph A. Carrado, M.Sc., R.Ph.
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Top | Up
Page last updated
August 9, 2006
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