Bupropion Hydrochloride 150 mg
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) ( 1.1 ) prevention of seasonal affective disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder (MDD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with MDD. The efficacy of the sustained-release formulation of bupropion in the maintenance treatment of MDD was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see Clinical Studies ( 14.1 )] . 1.2 Seasonal Affective Disorder (SAD) Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD). The efficacy of bupropion hydrochloride extended-release tablets (XL) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in adult outpatients with a history of MDD with an autumn-winter seasonal pattern as defined in the DSM [see Clinical Studies ( 14.2 )] .
Actavis Pharma, Inc.
ROUND WHITE WPI 3331
WPI 3331 ROUND WHITE
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Bupropion Hydrochloride 150 mg
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets (XL), 150 mg of
BUPROPION HYDROCHLORIDE, USP are white to off-white, round, bi-convex, film-coated tablets with “ WPI ” over “ 3331 ” printed in black ink in bottles of 30 tablets (NDC 0591-3331-30), bottles of 90 tablets (NDC 0591-3331-19) and bottles of 500 tablets (NDC 0591-3331-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
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