Bupropion Hydrochloride 100 MG Oral Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets 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) ] . Bupropion hydrochloride tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
mylan pharmaceuticals inc.
ROUND BLUE M 435
M 435 ROUND BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion Hydrochloride Tablets, USP are available containing 75 mg or 100 mg of bupropion hydrochloride, USP. The 75 mg tablets are peach, film-coated, round, unscored tablets debossed with M on one side of the tablet and 433 on the other side. They are available as follows: NDC 0378-0433-01 bottles of 100 tablets NDC 0378-0433-05 bottles of 500 tablets The 100 mg tablets are light blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and 435 on the other side. They are available as follows: NDC 0378-0435-01 bottles of 100 tablets NDC 0378-0435-05 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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