NDA#:                                                   20-358

CHEMISTRY REVIEW#:                    4

DATE REVIEWED:              28-AUG-96           

SUBMISSION TYPE

DOCUMENT DATE

              CDER DATE

ASSIGNED DATE

AMENDMENT

14-MAY-96

15-MAY-96

20-MAY-96

NAME & ADDRESS OF APPLICANT

GLAXO WELLCOME INC

Five Moore Drive

Research Triangle Park, NC 27709

DRUG PRODUCT NAME

            Proprietary:

WELLBUTRIN SR

            Nonproprietary/Established/USAN:

Bupropion hydrochloride

            Code Name/#:

            Chem. Type/Ther. Class

PHARMACOLOGICAL CATEGORY/INDICATION:

ANTIDEPRESSANT/DEPRESSION

DOSAGE FORM:

TABLETS

STRENGTHS:

50, 100 and 150mg

ROUTE OF ADMINISTRATION:

Oral

DISPENSED:

XX Rx           ___OTC

CHEMICAL NAME, STRUCTURAL FORMULA, MOLECULAR FORMULA, MOLECULAR WEIGHT:

(±)-1-(3-chlorophenyl)-2-[1,1-dimethylethyl)amino]-1-propanone hydrochloride (USAN)

CAS #: 31677-93-7; 34911-55-2 (bupropion base)

C₁₃H₁₈CINO. HCl  Mol Wt:  276.21

CONCLUSIONS & RECOMMENDATIONS:

based on review of the Chemistry and Manufacturing Controls Section, we recommend that the the label storage statement revisions and the addition of a cap liner to the container system be APPROVED; we do not recommend approval of a 24 month

expiration date at this time or revision of the original dissolution specifications.

Methods Validation is still in progress.