bupropion hydrochloride xl bupropion hydrochloride tablet 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) ].
sandoz inc.
ROUND WHITE ST300
ST300 ROUND WHITE
Related Pills
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING Bupropion hydrochloride extended-release tablets, USP (XL) are spplied as: NDC Strength Quantity Description 0781-5528-31 150 mg bottle of 30 tablets white to off-white, round, film coated tablets printed with "ST 150" on one side 0781-5528-10 150 mg bottle of 1,000 tablets white to off-white, round, film coated tablets printed with "ST 150" on one side 0781-5529-31 300 mg bottle of 30 tablets white to off-white, round, film coated tablets printed with "ST 300" on one side 0781-5529-10 300 mg bottle of 1,000 tablets white to off-white, round, film coated tablets printed with "ST 300" on one 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 (XL) may have an odor.
More pills like ROUND ST300