bupropion hydrochloride tablet film coated extended release
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) is 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 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 )].
par pharmaceutical, inc.
ROUND WHITE A 102
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bupropion hydrochloride tablet film coated extended release
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE Extended-Release Tablets USP (XL) 150 mg, are white to off-white, round tablets, printed with “A101”. They are supplied as follows: Bottles of 30 NDC # 10370-101-03 Bottles of 500 NDC # 10370-101-50
BUPROPION HYDROCHLORIDE Extended-Release Tablets USP (XL) 300 mg, are white to off-white, round tablets, printed with “A102”. They are supplied as follows: Bottles of 30 NDC # 10370-102-03 Bottles of 500 NDC # 10370-102-50 Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers. Protect from light.
BUPROPION HYDROCHLORIDE extended-release tablets (XL) may have an odor.
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