[Logo - CDER] CHEMISTRY REVIEW TEMPLATE
[Logo - CDER] |
Chemistry Assessment Section
8.
DRUG
PRODUCT NAME/CODE/TYPE:
a)
Proprietary
Name: Wellbutrin XLTM
b)
Non-Proprietary
Name / USAN: bupropion hydrochloride
c)
Code
Name/# (ONDC only): N/A
d)
Chem.
Type/Submissions Priority (ONDC only):
·
Chem.
Type: 3
·
Submission
Priority: S
9.
LEGAL
BASIS FOR SUBMISSION: 505(B)(1)
10. PHARMACOL. CATEGORY: Treatment of major depressive disorder
11. DOSAGE FORM: Extended Release Tablets
12. STRENGTH/POTENCY: 150 mg and 300 mg
13. ROUTE OF ADMINISTRATION: oral
14. Rx/OTC DISPENSED: _X_Rx _OTC
15. SPOTS (SPECIAL PRODUCTS ON-LINE TRACKING SYSTEM):
____ SPOTS product – Form
Completed
__X_ Not a SPOTS product
16.
CHEMICAL
NAME, STRUCTURAL FORMULA, MOLECULAR FORMULA, MOLECULAR WEIGHT:
Chemical
Name: (±)-2-(tert-butylamino)-3’-chloropropiophenone hydrochloride
Molecular
Formula: C13H18C1NO·HCl
Molecular Weight: 276.20
Page 5 of 16
Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page