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2005P-0291:
FDA to refuse to approve ANDA or Section 505(b)(2),for inhalation
Drug Products Containing a Combination of the Active Ingredients
Albuterol Sulfate and Ipratropium Hydrochloirde Administered by
Nebulization for the Treatment of Chronic Pulmonary Obstructive
Disorder
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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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| 07/25/2005
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| 07/26/2005
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| Private Industry
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| Frommer Lawrence and
Haug LLP
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| Table
of Contents
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| Signature:
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| Charles J. Raubicheck
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| ACK1
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| 07/26/2005
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| 07/26/2005
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| Federal Government
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| HFA-305 to Frommer
Lawrence and Haug LLP
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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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| 01/24/2006
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| 01/24/2006
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| Federal Government
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| HFD-005 to Frommer
Lawrence and Haug 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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| 12/26/2006
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| 12/21/2006
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| Federal Government
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| FDA/CDER to Charles
J. Raubicheck
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| pdf
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| Signature:
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| Steve Galson.M.D., M.P.H.
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Top
| Up
Page last updated:
March 7, 2007
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