ANDA 216051, held by Aurobindo Pharma Ltd. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 216051 (Bupropion Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Jul 21, 2026, with 0 approved supplements and 0 published complete response letters.
Bupropion hydrochloride extended-release tablets (XL) are an aminoketone antidepressant, indicated for: treatment of major depressive disorder (MDD) prevention of seasonal affective disorder (SAD) 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 2026 | Original application | Approved |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride300MG · 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
