Wellbutrin XL NDA 21-515

(sOP&K4S&17.27c66F 03-AUG-2003 FDA CDER EES Page 1 of 3

ESTABLISHMENT EVALUATION REQUEST

DETAIL REPORT

Application: NDA 21515/000 Action Goal:

Stamp: 26-AUG-2002 District Goal: 27-APR-2003

Regulatory Due: 03-SEP-2003 Brand Name: WELLBUTRIN XL (BUPROPION

Applicant: SMITHKLINE BEECHAM CORP DBA GL Estab. Name: HCL) EXTENDED REL

1 FRANKLIN PLAZA Generic Name: BUPROPION HCL EXTENDED

PHILADELPHIA, PA 19101 RELEASE TABLETS

Priority: 3S Dosage Form: (TABLET)

Org Code: 120 Strength: 150 MG AND 300 MG

Application Comment:

DA Contacts: D. BATES (HFD-120) 301-594-5536 , Project Manager

S. MCLAMORE (HFD-810) 310-594-5359 , Review Chemist

T. OLIVER (HFD-810) 310-594-2570 , Team Leader

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Overall Recommendation: ACCEPTABLE on 31-JUL-2003 by S. FERGUSON (HFD-322) 301-827-9009

ACCEPTABLE on 21-APR-2003 by S. FERGUSON (HFD-322) 301-827-9009

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Establishment: CFN 9615235 FEI 300280613

BIOVAIL LIFESCIENCES

STEINBACH, MANITOBA CA

MB No: AADA:

Responsibilities: FINISHED DOSAGE MANUFACTURER

FINISHED DOSAGE PACKAGER

FINISHED DOSAGE RELEASE TESTER

FINISHED DOSAGE STABILITY TESTER

Profile: TCT OAI Status: None

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Milestone Name Date Type Insp. Date Decision & Reason Creator

SUBMITTED TO OC 27-SEP-2002 MCLAMORES

SUBMITTED TO DO 30-SEP-2002 GMP DAMBROGIOJ

TO RECOMMENDATION 07-OCT-2002 ACCEPTABLE DAMBROGIOJ