bupropion hydrobromide
bupropion hydrobromide is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Aplenzin. Available dosage forms: powder, tablet, extended release.
Drug Details
- Generic Name
- bupropion hydrobromide
- Brand Names
- Aplenzin
- Application Number
- NDA022108
- Sponsor
- Jubilant Biosys limited
- NDC Codes
- 4
- Dosage Forms
- POWDER, TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- BUPROPION HYDROBROMIDE
Indications and Usage
1 INDICATIONS AND USAGE Bupropion Hydrobromide Extended-Release Tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. ( 1 ) 1.1 Major Depressive Disorder Bupropion Hydrobromide Extended-Release Tablets 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 Bupropion Hydrobromide Extended-Release Tablets 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) ].