bupropion hydrochloride 150 mg
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets, USP (XL) are 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, USP (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, USP (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 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)].
sun pharmaceutical industries, inc.
ROUND WHITE L2
L2 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE Extended-Release Tablets, USP (XL), 150 mg of
BUPROPION HYDROCHLORIDE, USP are white to pale yellow, round, film-coated tablets imprinted with L2 in black ink on one side and plain on the other side and are supplied as follows: NDC 63304-723-30 Bottles of 30 with child-resistant closure NDC 63304-723-90 Bottles of 90 with child-resistant closure NDC 63304-723-05 Bottles of 500 Store at 20ºC to 25ºC (68ºF to 77ºF). [See USP Controlled Room Temperature.]
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