bupropion hydrochloride 150 MG 12 HR Extended Release Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (SR) are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 ) 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) ] .
Wockhardt USA LLC.
ROUND PURPLE W 105
W 105 ROUND PURPLE
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets, USP (SR), 100 mg of bupropion hydrochloride, are blue, round, biconvex, film coated tablets with bevelled edge, debossed with 'W' on one side and '101' on the other side in Bottles of 30 Tablets (NDC - 64679-101-01) Bottles of 60 Tablets (NDC - 64679-101-02) Bottles of 100 Tablets (NDC - 64679-101-03) Bottles of 500 Tablets (NDC - 64679-101-07) Unit dose package of 100 (NDC 64679-101-05) Bupropion hydrochloride extended-release tablets, USP (SR), 150 mg of bupropion hydrochloride, are purple, round, biconvex, film coated tablets with bevelled edge, debossed with 'W' on one side and plain on the other side in 105 Bottles of 30 Tablets (NDC - 64679-105-01) Bottles of 60 Tablets (NDC - 64679-105-02) Bottles of 100 Tablets (NDC - 64679-105-03) Bottles of 500 Tablets (NDC - 64679-105-04) Unit dose package of 100 (NDC 64679-105-05) Bupropion hydrochloride extended-release tablets, USP (SR), 200 mg of bupropion hydrochloride, are pink, round, biconvex, film coated tablets with bevelled edge, debossed with 'W' on one side and plain on the other side in 107 Bottles of 30 Tablets (NDC - 64679-107-01) Bottles of 60 Tablets (NDC - 64679-107-02) Bottles of 100 Tablets (NDC - 64679-107-03) Bottles of 500 Tablets (NDC - 64679-107-04) Unit dose package of 100 (NDC 64679-107-05) Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Protect from light and moisture.
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