[Logo - CDER]                CHEMISTRY REVIEW TEMPLATE           [Logo - CDER]

Chemistry Assessment Section

 

8.     DRUG PRODUCT NAME/CODE/TYPE:

 

a)      Proprietary Name: Wellbutrin XL^TM

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 4444

 

 

Back a Page
Next Page
Back to Wellbutrin XL NDA Index Page
Back to Main Index Page