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) ].
accord healthcare inc.
ROUND WHITE GS1
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE extended-release tablets, USP (XL) are supplied as: NDC Strength Quantity Description 16729-443-10 150 mg bottle of 30 tablets creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-443-15 150 mg bottle of 90 tablets creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-443-16 150 mg bottle of 500 tablets creamy-white to pale yellow, round tablets printed with “GS1” on one side and plain on the other side 16729-444-10 300 mg bottle of 30 tablets creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side 16729-444-15 300 mg bottle of 90 tablets creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side 16729-444-16 300 mg bottle of 500 tablets creamy-white to pale yellow, round tablets printed with “GS2” on one side and plain on the other side 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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