ANDA 211200, held by Zhejiang Jutai Pharm. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 211200 (Bupropion Hydrochloride), held by Zhejiang Jutai Pharm, was first approved by FDA on Sep 5, 2019, with 4 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 |
|---|---|---|---|
| Sep 5, 2019 | Original application | Approved | None posted |
| Bupropion Hydrochloride300MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Dec 19, 2024 | Supplement 7Manufacturing | Approved | None posted |
| Oct 1, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 1, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 1, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 5, 2019 | Original application | Approved | None posted |
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
