ANDA 90325, held by Aurobindo Pharma USA. Bupropion Hydrochloride.
As of Nov 15, 2026, ANDA 90325 (Bupropion Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Apr 8, 2010, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 2010 | Original application | Approved | None posted |
| Bupropion Hydrochloride100MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride150MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Bupropion Hydrochloride200MG · tablet, extended release;oral | Bupropion Hydrochloride | Rx |
| Jan 10, 2025 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 10, 2025 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 21, 2020 | Supplement 15Labeling · Standard review | Approved | None posted |
| Dec 21, 2020 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 21, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jun 12, 2017 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 11, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 11, 2015 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 7, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 7, 2014 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 2, 2013 | Supplement 8Manufacturing | Approved | None posted |
| Aug 8, 2011 | Supplement 5Manufacturing | Approved | None posted |
| Apr 8, 2010 | 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
