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bupropion hydrochloride xl bupropion hydrochloride tablet extended release

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet (XL) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder 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 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.


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5 days ago ROUND WHITE T 102 bupropion hydrochloride xl bupropion hydrochloride tablet extended release

ROUND WHITE T 102

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE extended-release tablets USP (XL), 150 mg of

BUPROPION HYDROCHLORIDE, are round, white film coated tablets printed with "T101" in black ink on one side and plain on the other side and are available in bottles of 30 tablets (NDC 24979-101-06), 90 tablets (NDC 24979-101-07) and 500 tablets (NDC 24979-101-02).

BUPROPION HYDROCHLORIDE extended-release tablets USP (XL), 300 mg of

BUPROPION HYDROCHLORIDE, are round, white film coated tablets printed with "T102" in black ink on one side and plain on the other side and are available in bottles of 30 tablets (NDC 24979-102-06), 90 tablets (NDC 24979-102-07) and 500 tablets (NDC 24979-102-02). Store at 20° to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from light.

BUPROPION HYDROCHLORIDE extended-release tablets (XL) may have an odor.

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