[Logo CDER] CHEMISTRY REVIEW
TEMPLATE [Logo CDER] |
Chemistry Assessment Section
17.RELATED/SUPPORTING DOCUMENTS:
A.
DMFs:
DMR# |
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 |
9-29-00 |
N/A |
[blacked out] |
Type III |
[blacked out] |
[blacked out] |
1 |
Adequate |
9-29-00 |
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 Table:
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 |
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