[Logo CDER]          CHEMISTRY REVIEW TEMPLATE                 [Logo CDER]

Table of Contents .......................................................................................................

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Chemistry Review Data Sheet ......................................................................................

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The Executive Summary ..............................................................................................

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I.   Recommendations.............................................................................................................................

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     A.  Recommendation and Conclusion on Approvability ..............................................................................

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     B.  Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management           Steps, If Approvable ...........................................................................................................................

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II.  Summary of Chemistry Assessments .......................................................................................................

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     A.  Description of the Drug Products(s) and Drug Substance(s) .................................................................

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     B.  Description of How the Drug Product is Intended to be Used ...............................................................

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     C.  Basis for Approvability or Not-Approval Recommendation ...................................................................

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III. Administrative ........................................................................................................................................

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     A. Reviewer’s Signature .........................................................................................................................

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     B.  Endorsement Block ............................................................................................................................

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     C.  CC Block ..........................................................................................................................................

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Chemistry Assessment ................................................................................................

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