[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 Product(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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I.     DRUG SUBSTANCE ...........................................................................................................................

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       1.  Description & Characterization .........................................................................................................

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            a.  Description .................................................................................................................................

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            b.  Characterization /Proof of Structure .............................................................................................

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       2.  Manufacturer ...................................................................................................................................

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       3.  Synthesis / Method of Manufacture ...................................................................................................

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            a.  Starting Materials – Specs & Tests ..............................................................................................

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            b.  Solvents, Reagents, etc. ...............................................................................................................

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            c.  Flow Chart ..................................................................................................................................

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            d.  Detailed Description ....................................................................................................................

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       4.  Process Controls ..............................................................................................................................

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            a.  Reaction Completion / Other In-Process Tests ..............................................................................

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            b.  Intermediate Specs & Tests .........................................................................................................

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       5.  Reference Standard ..........................................................................................................................

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