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 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 ) ].
Granules Pharmaceuticals Inc.
ROUND WHITE G 784
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) are supplied as 150 mg, creamy-white to pale yellow round coated tablets imprinted with G784 on one side and plain on other side.
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) are supplied as 300 mg, creamy-white to pale yellow round coated tablets imprinted with G785 on one side and plain on other side. Strength Quantity NDC 150 mg Bottles of 30 tablets Bottles of 90 tablets Bottles of 500 tablets 70010-784-03 70010-784-09 70010-784-05 300 mg Bottles of 30 tablets Bottles of 90 tablets Bottles of 500 tablets 70010-785-03 70010-785-09 70010-785-05 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
BUPROPION HYDROCHLORIDE extended-release tablets (XL) may have an odor.
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