ANDA 79094, held by Actavis Labs Fl Inc. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 79094 (Bupropion Hydrochloride), held by Actavis Labs Fl Inc, was first approved by FDA on Mar 24, 2009, with 13 approved supplements and 0 published complete response letters.
Bupropion hydrochloride extended-release tablets (SR) are indicated as an aid to smoking cessation treatment.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Nov 6, 2025 | Supplement 44Labeling · Standard review | Approved | None posted |
| May 7, 2024 | Supplement 36Labeling · Standard review | Approved | None posted |
| Apr 3, 2024 | Supplement 35Labeling · Standard review | Approved | None posted |
| Apr 3, 2024 | Supplement 33Labeling · Standard review | Approved | None posted |
| Apr 3, 2024 | Supplement 30Labeling · Standard review | Approved | None posted |
| Jun 30, 2017 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jun 14, 2015 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jun 14, 2015 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jun 14, 2015 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 16, 2013 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 18, 2012 | Supplement 11Labeling | Approved | None posted |
| Apr 27, 2010 | Supplement 8REMS | Approved | None posted |
| Nov 16, 2009 | Supplement 5Labeling | Approved | None posted |
| Mar 24, 2009 | 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
