(c) 2023 PillSync.com

bupropion hydrochloride tablet extended release

1 INDICATIONS AND USAGE Bupropion hydrochloride extended-release tablets (XL) are 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) ].

ScieGen Pharmaceuticals,Inc.


5 years ago ROUND WHITE 144 bupropion hydrochloride tablet extended release

ROUND WHITE 144

5 years ago ROUND WHITE 144 bupropion hydrochloride tablet extended release

144 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE extended-release tablets USP (XL), 150 mg, are white to pale yellow, round, biconvex, film coated tablets, debossed with ‘144’ on one side and plain on other side in bottles of 30 (NDC 50228-144-30), 90 (NDC 50228-144-90) and 500 (NDC 50228-144-05).

BUPROPION HYDROCHLORIDE extended-release tablets USP (XL), 300 mg, are white to pale yellow, modified capsule-shaped, biconvex, film coated tablets, debossed with ‘145’ on one side and plain on other side in bottles of 30 (NDC 50228-145-30) , 90 (NDC 50228-145-90) and 500 (NDC 50228-145-05). Store at 25 o C (77 o F); excursions permitted to 15 o C to 30 o C (59 o F to 86 o F) [see USP Controlled Room Temperature].

BUPROPION HYDROCHLORIDE extended-release tablets (XL) may have an odor.

More pills like ROUND 144












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