Treats major depressive disorder (MDD). ANDA 206674, held by Invagen Pharms. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 206674 (Bupropion Hydrochloride), held by Invagen Pharms, was first approved by FDA on Feb 9, 2016, with 4 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 tablet (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 |
|---|---|---|---|
| Feb 9, 2016 | Original application | Approved |
| Bupropion Hydrochloride100MG · tablet, extended release;oral | Bupropion Hydrochloride | Discontinued |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Discontinued |
| Bupropion Hydrochloride200MG · tablet, extended release;oral | Bupropion Hydrochloride | Discontinued |
| Jan 4, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 4, 2021 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 4, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 17, 2017 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 9, 2016 | Original application | Approved |
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
