bupropion hydrochloride xl bupropion hydrochloride tablet extended release
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) ].
twi pharmaceuticals, inc.
ROUND WHITE T102
T102 ROUND WHITE
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bupropion hydrochloride xl bupropion hydrochloride tablet extended release
twi pharmaceuticals, inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets USP (XL) extended-release tablets are supplied as: NDC Number Strength Quantity Description 24979-101-06 150 mg bottle of 30 tablets round, white film coated tablets printed with T101 on one side and plain on the other side 24979-101-07 150 mg bottle of 90 tablets 24979-101-02 150 mg bottle of 500 tablets 24979-102-06 300 mg bottle of 30 tablets round, white film coated tablets printed with T102 on one side and plain on the other side 24979-102-07 300 mg bottle of 90 tablets 24979-102-02 300 mg bottle of 500 tablets Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.
BUPROPION HYDROCHLORIDE extended-release tablets (XL) may have an odor.
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