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 )
Mylan Pharmaceuticals Inc.
ROUND GREEN M U13
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are available containing 100 mg, 150 mg or 200 mg of bupropion hydrochloride, USP. The 100 mg tablets are light-green, film-coated, round, unscored tablets debossed with M over U11 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3411-01 bottles of 100 tablets NDC 0378-3411-05 bottles of 500 tablets The 150 mg tablets are light-green, film-coated, round, unscored tablets debossed with M over U12 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3412-01 bottles of 100 tablets NDC 0378-3412-05 bottles of 500 tablets The 200 mg tablets are light-green, film-coated, round, unscored tablets debossed with M over U13 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-3413-01 bottles of 100 tablets NDC 0378-3413-05 bottles of 500 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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