Table of Contents

NDA 21-515

Wellbutrin XLTM (bupropion hydrochloride)

150 and 300 mg Extended-Release Tablets

 

Approval Package;

Volume 1 of 1

 

A.     Table of Contents

B.     Action Package Checklist (for AP action)

C.     Action Letter with Labeling

§   Approval letter [Letter] and Labeling

§   Approvable Letter and Labeling

D.     Labeling

§   Agreed-upon labeling for AP action (see Tab C)

§   Comparison of Agreed-upon AP labeling to FDA’s AE labeling

§   Most recent version of Applicant’s Proposed Wellbutrin XL insert, marked up and clean

§   Applicant’s proposed 7/3/03 version, marked up and clean

§   Container / Carton Labeling

§   Current Wellbutrin insert

§   Current Wellbutrin SR insert

 

E.      Patent Information (certification, exclusivity request from applicant)

F.      Exclusivity Checklist

G.     Pediatric Information

§   Partial deferral and partial waiver request from firm (Pediatric Rule has been suspended)

§   Pediatric Page

§   Pediatric WR for bupropion, with reports due February, 2004, covers exclusivity for all bupropion dosage forms under the Pediatric Exclusivity provisions (WR copy attached)

H.     User Fee Information and Debarment Certification (see AE package)

I.        DSI (completed in first review cycle; see AE package)

J.       Division Director Memo

K.     Clinical Team leader Memo

L.      Clinical Review

M.    Safety Review (see clinical review)

Mc. Consult Reviews

§   Resubmission review of proposed trademark

§   Reviews of patient labeling, container labeling, patient education proposals (J. Best, D. Toyer)

N.     Statistical Review (not needed for this submission)

O.     Biopharmaceutics / Clinical Pharmacology Review

P.      Pharmacology Review (not needed for this submission: cross-reference provided)

 

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