NDA 21-515
WELLBUTRINTM XL
(bupropion hydrochloride) Extended-Release Tablets
GUIDE TO FDA REVIEWERS
1. Electronic
Submission
All documents included in this submission are provided as electronic files in Portable Document Format (PDF). The submission has been organized into a folder-based structure in compliance with the guidance for providing regulatory submissions in electronic format (IT3 January 1999). All components of this submission have likewise been organized into the folder-based structure that was described in the guidance document. An electronic table of contents (amendtoc.pdf), located in folder ‘N02515’ allows the reviewer to access any report or summary within the submission. The reviewer will be able to view the information, copy and paste the information to a review commentary, and/or print the information, if needed.
2. Electronic
Description
Contents of the media: one copy of one CD as the electronic archive copy and labeled ELECTRONIC REGULATORY SUBMISSION FOR ARCHIVE.
Total size of the submission (Approx. 1.15mg)
3. Virus
Verification
This submission is virus-free and confirmed via McAfee VirusScan w/SP v4.5.0.534 (4287).
STAMPED: APPEARS THIS
WAY ON ORIGINAL
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