DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

APPLICATION TO MARKET A NEW DRUG, BIOLOGIC, OR AN ANTIBIOTIC DRUG FOR HUMAN USE

(Title 21, Code of Federal Regulations, Parts 314 & 601)

Form Approved: OMB No. 0910-0338

Expiration Date: March  31, 2005

See OMB Statement on page 2

FOR FDA USE ONLY

APPLICATION NUMBER

APPLICANT INFORMATION

NAME OF APPLICANT

SmithKline Beecham Corporation d/b/a GlaxoSmithKline

DATE OF SUBMISSION

July 3, 2003

TELEPHONE NO. (Include Area Code)

919-483-2100

FACSIMILE (FAX) Number (Include Area Code)

(919) 483-5756

APPLICANT ADDRESS (Number, Street, City, State, Country, ZIP Code or Mail Code, and U.S. License number if previously issued):

One Franklin Plaza

P.O. Box 7929

Philadelphia, PA 19101

AUTHORIZED U.S. AGENT NAME & ADDRESS (Number, Street, City, State, ZIP Code, telephone & FAX number) IF APPLICABLE

PRODUCT DESCRIPTION

NEW DRUG OR ANTIBIOTIC APPLICATION NUMBER, OR BIOLOGICS LICENSE APPLICATION NUMBER (If previously issued)

21-515

ESTABLISHED NAME (E.G. Proper name, USP/USAN name)

Bupropion hydrochloride

PROPRIETARY NAME (trade name) IF ANY

WELLBUTRIN XL^TM

CHEMICAL/BIOCHEMICAL/BLOOD PRODUCT NAME (If any)

CODE NAME (If any)

DOSAGE FORM:

Tablets

STRENGTHS:

150 mg, 300 mg

ROUTE OF ADMINISTRATION

Oral

(PROPOSED) INDICATION(S) FOR USE:

APPLICATION INFORMATION

APPLICATION TYPE

(check one)     (X) NEW DRUG APPLICATION (21 CFR 314.50     ( ) ABBREVIATED NEW DRUG APPLICATION (ANDA, 21 CFR 314.94)

( ) BIOLOGICS LICENSE APPLICATION (21 CFR Part 601)

IF AN NDA, IDENTIFY THE APPROPRIATE TYPE    (X) 505 (b)(1)         ( ) 505 (b)(2)

IF AN ANDA, OR 505(b)(2), IDENTIFY THE REFERENCE LISTED DRUG PRODUCT THAT IS THE BASIS FOR THE SUBMISSION

Name of Drug ______________________________                                     Holder of Approved Application _______________________

TYPE OF SUBMISSION (check one) ( ) ORIGINAL APPLICATION ( ) AMENDMENT TO APENDING APPLICATION ( ) RESUBMISSION

( ) PRESUBMISSION  ( ) ANNUAL REPORT  ( ) ESTABLISHMENT DESCRIPTION SUPPLEMENT  ( ) EFFICACY SUPPLEMENT

    ( ) LABELING SUPPLEMENT          ( ) CHEMISTRY MANUFACTURING AND CONTROLS SUPPLEMENT     (X) OTHER

IF A SUBMISSION OF PARTIAL APPLICATION, PROVIDE LETTER DATE OF AGREEMENT TO PARTIAL SUBMISSION:

IF A SUPPLEMENT, IDENTIFY THE APPROPRIATE CATEGORY   ( ) CBE     ( ) CBE-30     ( ) PRIOR APPROVAL (PA)

REASON FOR SUBMISSION  Response to Approvable Leeter: Clinical Pharmacology, CMC, Labeling, Safety

PROPOSED MARKETING STATUS (check one)  (X) PRESCRIPTION PRODUCT R_X     ( ) OVER THE COUNTER PRODUCT (OTC)

NUMBERS OF VOLUMES SUBMITTED _1

__ THIS APPLICATION IS ( ) PAPER   ( ) PAPER AND ELECTRONIC   (X) ELECTRONIC

ESTABLISHMENT INFORMATION (Full establishment information should be provided in the body of the Application.)

Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary).  Include name, address, contact, telephone number, registration number (CFN), DMF number, and manufacturing steps and/or type of testing (e.g. Final dosage form, Stability testing) conducted at the site.  Please indicate whether the site is ready for inspection or, if not, when it will be ready.

Drug Product Manfacturer – Ready for inspection                                            GlaxoSmithKline Contact (all other sites)

Biovail Corporation, Manufacturing Division                                                   Steve Moss, Compliance Manager, Europe/International

100 LifeSciences Parkway                                                                                Harmire Road

Steinback, MB, Canada                                                                                     Barnard Castle, County Durham, DL128DT, UK

Contact: Hanif Sachedina, Director, Corporate Compliance                             +44 (0) 183 369 0600

(416) 285-6000 x217

Cross Reference (list related License Applications, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, and DMFs referenced in the current application)