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2005P-0493:
Establish Criteria, Analogous to the Criteria for Marketing Category
I Drug Products under OTC Drug Review Regarding the Substitutability
of Prescription Hyoscyamine Drug Products
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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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| 12/15/2005
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| 12/15/2005
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| Drug Industry
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| Breckenridge Pharmaceutical,
Inc.
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| pdf
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| Signature:
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| Edward John Allera
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| ACK1
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| 12/15/2005
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| 12/15/2005
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| Federal
Government
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| HFA-305 to Buchanan
Ingersol PC
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| pdf
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| Signature:
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| Lyle D. Jaffe
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| LET1
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| 06/12/2006
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| 06/12/2006
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| Federal Government
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| FDA/CDER to Buchanan
Ingersoll PC
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| pdf
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| Signature:
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| Jane A. Axelrad
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Top | Up
Page last updated
July 5, 2006
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