NDA#:                                                   20-358

CHEMISTRY REVIEW#:                    2

DATE REVIEWED:              07-MAR-95

SUBMISSION TYPE

DOCUMENT DATE

              CDER DATE

ASSIGNED DATE

ORIGINAL

13-APR-93

13-APR-93

21-APR-93

RESUBMITTED

28-FEB-94

28-FEB-94

AMENDMENT

02-FEB-95

10-FEB-05

13-FEB-95

NAME & ADDRESS OF APPLICANT

BURROUGHS WELLCOME COMPANY

3030 Cornwallis Road

Research Triangle Park, NC 27709

DRUG PRODUCT NAME

            Proprietary:

WELLBUTRIN® SR

            Nonproprietary/Established/USAN:

Bupropion hydrochloride

            Code Name/#:

            Chem. Type/Ther. Class

ANDA Suitability Petition / DESI / Patent Status:

N/A

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:

2-tert-butylamino-3’-chloropropiophenone hydrochloride (±)

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

Molecular Formula: C₁₃H₁₈CINO. HCl 

Moleculary Weight:            276.21

WELLBUTRIN (Bupropion hydrochloride)

CONCLUSIONS & RECOMMENDATIONS:

Based on review of the Chemistry and Manufacturing Controls Section of this submission, recommend that submission be considered UNAPPROVABLE until validation of the regulatory test methods and satisfactory response to chemist’s deficiency letter regarding expiry date are completed or implemented.