Table of Contents

NDA 21-515

Wellbutrin XL^TM (bupropion hydrochloride)

150 and 300 mg Extended-Release Tablets

 

Q.     Chemistry Review

§         Chemistry Review of Resubmission

§         Establishment Inspection Report (EES)

§         Environmental Assessment (Categorical Exclusion) Granted in First Review Cycle.

R.     Correspondence

§         Applicant to FDA

§         FDA to Applicant

S.      Minutes of Meetings

T.      ISE (See EDR submission)

U.     ISS (See EDR submission)

V.     Submission History

§         Log of Documents Submitted to NDA (DSS and EDR versions)

 

 

Stamped: APPEARS THIS WAY ON ORIGINAL

 

 

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