720 J2wlz14m11; 90s Summary Basis of Approval
Cover Form
Appl #: 020358 Firm: Glaxo Wellcome
Reviewing Div: 120
Trade Name: WELLBUTRIN (BUPROPION HCL) SR TABLETS
Generic Name:
BUPROPION HYDROCHLORIDE
|
Approval Letter: |
Y |
|
Statistician Review: |
Y |
|
SBA Form: |
N |
|
Bio/Dissolution Review: |
Y |
|
Final Printed Labeling: |
N |
|
Microbiologist Review: |
N |
|
Medical Officer Review: |
Y |
|
NAS/NRC Review: |
N |
|
Chemist Review: |
Y |
|
Pharmacologist Review: |
Y |
|
Federal Register Notice: |
N |
|
Completion Data: |
11-APR-97 |
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