CENTER FOR DRUG EVALUATION AND RESEARCH

 

Approval Package for:

 

APPLICATION NUMBER:

 

21-515

 

Trade Name:          Wellbutrin XL Tablet

 

Generic Name:       Bupropion HCl

 

Sponsor:                 GlaxoSmithKline

 

Approval Date:       August 28, 2003

 

Indications:            Provides for the use of Wellbutrin XL tablets as a new

extended-release formulation of bupropion.

Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page