Treats major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). ANDA 207224, held by Anbison Lab. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 207224 (Bupropion Hydrochloride), held by Anbison Lab, was first approved by FDA on Jun 30, 2017, with 5 approved supplements and 0 published complete response letters.
Bupropion hydrochloride extended-release tablets (XL) is an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. 1.1 Major Depressive Disorder
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2017 | Original application | Approved | None posted |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride300MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Oct 7, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 23, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 5, 2018 | Supplement 3Manufacturing | Approved | None posted |
| Jun 30, 2017 | 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
