bupropion 300 mg
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablet (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 (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 )].
Lupin Pharmaceuticals, Inc.
ROUND WHITE L016
L016 ROUND WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Caption: NDC Strength Quantity Description 68180-319-06 150 mg Bottles of 30's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L015" in black ink on one side and plain on the other side 68180-319-09 150 mg Bottles of 90's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L015" in black ink on one side and plain on the other side 68180-319-02 150 mg Bottles of 500's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L015" in black ink on one side and plain on the other side 68180-320-06 300 mg Bottles of 30's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L016" in black ink on one side and plain on the other side 68180-320-09 300 mg Bottles of 90's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L016" in black ink on one side and plain on the other side 68180-320-02 300 mg Bottles of 500's off-white to pale yellow, round, biconvex, coated tablets imprinted with "L016" in black ink 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].
BUPROPION HYDROCHLORIDE extended-release tablets USP (XL) may have an odor.
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