BUPROPION HYDROCHLORIDE SR
BUPROPION HYDROCHLORIDE SR is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including BUPROPION HYDROCHLORIDE SR. Available dosage form: tablet, film coated, extended release.
Drug Details
- Generic Name
- BUPROPION HYDROCHLORIDE SR
- Brand Names
- BUPROPION HYDROCHLORIDE SR
- Application Number
- ANDA205794
- Sponsor
- DirectRx
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- BUPROPION HYDROCHLORIDE
Indications and Usage
Bupropion hydrochloride extended-release tablets (SR) is 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)] .