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bupropion hydrochloride tablet extended release

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are 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) ].

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7 days ago ROUND WHITE GS1 bupropion hydrochloride tablet extended release

ROUND WHITE GS1

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) 150 mg are creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 16729-443-10) Bottles of 90 (NDC 16729-433-15) Bottles of 500 (NDC 16729-433-16)

BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) 300 mg are creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side. They are supplied as follows: Bottles of 30 (NDC 16729-444-10) Bottles of 90 (NDC 16729-444-15) Bottles of 500 (NDC 16729-444-16) 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, USP (XL) may have an odor.

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