bupropion hydrochloride 300 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 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) ] .
method pharmaceuticals, llc
ROUND PINK 189
189 ROUND PINK
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets, USP (XL) are supplied as: Bupropion hydrochloride extended-release tablets, USP (XL) 150 mg are pink round biconvex coated tablet imprinted with '188' in black ink on one side and plain on other side. They are available as follows. Bottles of 30 tablets with child-resistant closure, NDC 58657-712-30 Bottles of 90 tablets with child-resistant closure, NDC 58657-712-90 Bottles of 500 tablets, NDC 58657-712-50 Bupropion hydrochloride extended-release tablets, USP (XL) 300 mg are pink round biconvex coated tablet imprinted with '189' in black ink on one side and plain on the other side. They are as follows. Bottles of 30 tablets with child-resistant closure, NDC 58657-713-30 Bottles of 90 tablets with child-resistant closure, NDC 58657-713-90 Bottles of 500 tablets, NDC 58657-713-50 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Bupropion hydrochloride extended-release tablets, USP (XL) may have an odor.
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