1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet, (XL) is 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) ].
cipla usa inc.,
16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL), 150 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with â€˜Iâ€™ on one side and â€˜13â€™ on the other side and are available in bottles of 30 tablets (NDC 69097-875-02), bottles of 90 tablets (NDC 69097-875-05) and bottles of 500 tablets (NDC 69097-875-12).
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL), 300 mg are white to off white capsule shaped, biconvex coated tablets de-bossed with â€˜I 71â€™ on one side and plain on the other side and are available in bottles of 30 tablets (NDC 69097-876-02) and bottle of 500 tablets (NDC 69097-876-12) . Store bupropion HCl extended-release tablets at 20Â° to 25Â°C (68Â°F to 77Â°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP .
exelan pharmaceuticals inc.
exelan pharmaceuticals inc.
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