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2005P-0458:
Refrain from Approving ANDA 77-271 Until the Three-year Period of
Market Exclusivity for the Product has Expired
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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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11/14/2005
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11/14/2005
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Private Industry
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Medi-Flex, Inc.
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Table
of Contents |
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Signature: |
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Jeffrey P. Kushan
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ACK1 |
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11/14/2005
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11/14/2005
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Federal Government |
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HFA-305 to Sidley
Austin Brown & Wood LLP |
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pdf |
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Signature: |
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Lyle D. Jaffe |
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PSA1 |
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12/23/2005
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12/23/2005
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Private Industry
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Medi-Flex, Inc.
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Table
of Contents |
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Signature: |
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Daniel E. Tray |
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ACK2 |
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12/27/2005
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12/27/2005
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Federal Government |
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HFA-305 to Sidley
Austin Brown & Wood LLP |
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pdf |
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Signature: |
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Lyle D. Jaffe |
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C1 |
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01/20/2006
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01/20/2006
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Health Care
Association |
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Cardinal Health
Medical Products and Services (Cardinal) |
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pdf |
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Signature: |
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James N. Czaban |
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RC1 |
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03/03/2006
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03/03/2006
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Private Industry
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Medi-Flex, Inc.
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pdf
Attachments
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Signature: |
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Daniel E. Troy |
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LET1 |
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05/17/2006
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05/17/2006
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Federal Government |
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FDA/CDER to
Sidley Austin Brown & Wood LLP |
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pdf |
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Signature: |
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Jane A. Axelrad |
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MM1 |
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06/22/2006
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06/22/2006
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Federal Government |
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FDA/CDER and
Medi-Flex, Inc |
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pdf |
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Signature: |
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Dave Read |
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LST1 |
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06/22/2006
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06/22/2006
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Federal Government |
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Proposed Meeting
Agenda: ChloraPrep with Tint |
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pdf |
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Signature: |
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Dave Read |
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TS1 |
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06/22/2006
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06/22/2006
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Private Industry
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Medi-Flex, Inc
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pdf |
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Signature: |
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Medi-Flex, Inc |
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SUP1 |
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09/13/2006
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09/13/2006
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Private Industry
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Medi-Flex, Inc.
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pdf |
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| |
Signature: |
|
Daniel E. Troy |
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Top | Up
Page last updated
October 19, 2006
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