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Bupropion 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.


5 years ago
ROUND WHITE 141 Bupropion 150 mg

ROUND WHITE 141

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) 300 mg, are off-white, oval, biconvex film-coated tablets debossed with "142" on one side of the tablet and blank on the other side in bottles of 30 tablets (NDC 45963-142-30), 90 tablets (NDC 45963-142-90) and 500 tablets (NDC 45963-142-05). Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers as defined in the USP.

BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) may have an odor.


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