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2004P-0141: Petitioner Requests the Commissioner to Determine that NDA 19-44, Sodium Bicarbonate Injection in PET Abboject Vials was not withdrawn for Safety or Effectiveness Reasons
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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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| 03/22/2004
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| 03/23/2004
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| Drug Industry
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| Abbott
Laboratories
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| pdf
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| Signature:
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| Surendera K. Tyagi
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| ACK1
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| 03/23/2004
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| 03/23/2004
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| Federal
Government
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| HFA-305 to Abbott
Laboratories
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| EMC1
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| 05/28/2004
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| 05/28/2004
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| Other
Organization
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| Number not used
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| Signature:
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| Number not used
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| LET1
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| 09/17/2004
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| 09/17/2004
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| Federal
Government
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| HFD-005 to Abbott
Laboratories
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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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| 11/26/2004
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| FDA
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| FDA
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| 11/29/2004
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| 69373-69374
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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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| 12/06/2004
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| 12/06/2004
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| Federal
Government
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| HFD-7 to Abbott
Laboratories
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| pdf
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| Signature:
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| Nikki Mueller
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Page last updated:
August 24, 2007
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