| Up
2004P-0231:
Deny
Approval of NDA 21-426 for Ominitrop 5.8 mg Somatropin [rDNA origin]
for Injection, Lyophilized Powder and Diluent with Preservative
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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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| 05/14/2004
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| 05/14/2004
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| Federal Government
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| FDA/DDM to Pfizer
Inc.
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| pdf
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| Signature:
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| Jennie C. Butler
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| CP1
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| 05/14/2004
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| 05/14/2004
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| Private Industry
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| Pfizer Inc.
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| pdf
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| Signature:
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| Kathleen M. Sanzo
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| C1
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| 06/25/2004
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| 06/25/2004
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| Private Industry
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| Engel & Novitt,
LLP
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| Table
of Contents
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| Signature:
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| John M. Engel
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| SUP1
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| 08/10/2004
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| 08/10/2004
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| Private Industry
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| Pfizer Inc.
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| pdf
Tab
1 , 2-4
, 5 ,
6-8
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| See CP 1
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| C2
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| 11/12/2004
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| 11/12/2004
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| Drug Industry
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| Barr Laboratories,
Inc.
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| Table
of Contents
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| Signature:
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| Christine J. Siwik
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| LET1
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| 11/15/2004
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| 11/15/2004
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| Federal
Government
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| FDA/CDER to Morgan
Lewis & Bocklus LLP
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| pdf
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| Signature:
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| Jane A. Axelrad
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| PDN1
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| 05/31/2006
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| 05/31/2006
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| Federal Government
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| FDA/CDER to Morgan
Lewis & Bocklus LLP
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| pdf
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| Signature:
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| Steven K. Galson, M.D., M.P.H.
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Top | Up
Page last updated
July 11, 2006
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