Treats major depressive disorder (MDD). ANDA 220529, held by Yichang Humanwell. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 220529 (Bupropion Hydrochloride), held by Yichang Humanwell, was first approved by FDA on May 4, 2026, with 0 approved supplements and 0 published complete response letters.
Bupropion hydrochloride extended-release tablets (SR) are 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. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2026 | Original application | Approved | None posted |
| Bupropion Hydrochloride100MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride200MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
