12 HR Bupropion Hydrochloride 200 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14) ] . The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14) ] . Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Amneal Pharmaceuticals of New York LLC
ROUND ORANGE 555
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE Extended-Release Tablets (SR), 200 mg are pale orange, film-coated, round, convex tablets debossed with “555” on one side and plain on the other side. They are available as: Bottles of 60: NDC 0115-5445-13 Bottles of 180: NDC 0115-5445-19 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.
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