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Chemistry Assessment Section

 

a.       Proprietary Name:  Wellbutrin XL^TM

b.       Non-Proprietary Name / USAN: bupropion hydrochloride

c.       Code Name/# (ONDC only): N/A

d.       Chem. Type/Submission Priority (ONDC only):

 

·         Chem. Type: 3

·         Submission Priority: S

 

9.     LEGAL BASIS FOR SUBMISSION: 505(b)(1)

 

10. PHAMACOL. 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

 

 

17. RELATED/SUPPORTING DOCUMENTS:

 

 

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