|
[Logo CDER] CHEMISTRY REVIEW
TEMPLATE [Logo CDER] |
Chemistry Assessment Section
A.
DMFs:
|
DMF# |
TYPE |
HOLDER |
ITEM REFERENCED |
CODE1 |
STATUS2 |
DATE REVIEW COMPLETED |
COMMENTS |
|
[blacked out] |
Type II |
[blacked out] |
[blacked out] |
1 |
Adequate |
03-25-03 |
N/A |
|
[blacked out] |
TYPE
III |
[blacked out] |
[blacked out] |
1 |
Adequate |
9-26-00 |
N/A |
|
[blacked out] |
TYPE III |
[blacked out] |
[blacked out] |
1 |
Adequate |
9-28-00 |
N/A |
|
[blacked out] |
TYPE III |
[blacked out] |
[blacked out] |
1 |
Adequate |
8-7-97 |
N/A |
|
[blacked out] |
TYPE III |
[blacked out] |
[blacked out] |
1 |
Adequate |
3-2-00 |
N/A |
|
[blacked out] |
TYPE III |
[blacked out] |
[blacked out] |
1 |
Adequate |
3-20-01 |
N/A |
|
[blacked out] |
TYPE III |
[blacked out] |
[blacked out] |
1 |
Adequate |
06-11-99 |
N/A |
1Action codes for DMF
1 –
DMF Reviewed.
Other
codes indicate why the DMF was not reviewed, as follows:
2 –
Type 1 DMF
3 –
Reviewed previously and no revision since last review
4 –
Sufficient information in application
5 –
Authority to reference not granted
6 –
DMF not available
7 –
Other (explain under “Comments”)
2Adequate, Inadequate, or N/A
(There is enough data in the application, therefore the DMF did not need to be
reviewed)
B.
Other Documents
|
DOCUMENT |
APPLICATION NUMBER |
DESCRIPTION |
|
IND |
28,
676 |
Wellbutrin
SR® (bupropion hydrochloride) Sustained-Release
Tablets-antidepressant |
|
IND |
13,845 |
Wellbutrin®
(bupropion hydrochloride) Tablets-antidepressant |
|
IND |
36,571 |
Bupropion
Hydrochloride – cocaine dependence |
|
IND |
45,794 |
Bupropion
Hydrochloride –smoking cessation |
|
NDA |
18-644 |
Wellbutrin®
Tablets |
|
NDA |
20-358 |
Wellbutrin
SR® Tablets |
18. STATUS: [blacked out]
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