ANDA 77873, held by Aurobindo Pharma USA. Paroxetine Hydrochloride.
As of Nov 15, 2026, ANDA 77873 (Paroxetine Hydrochloride), held by Aurobindo Pharma USA, was first approved by FDA on Jun 29, 2007, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2007 | Original application | Approved |
| Paroxetine HydrochlorideEQ 12.5MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Paroxetine HydrochlorideEQ 25MG BASE · tablet, extended release;oral | Paroxetine Hydrochloride | Rx |
| Apr 6, 2026 | Supplement 28Labeling · Standard review | Approved | None posted |
| Apr 6, 2026 | Supplement 29Labeling · Standard review | Approved | None posted |
| May 4, 2021 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 4, 2021 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jul 15, 2015 | Supplement 21Labeling · Standard review | Approved | None posted |
| Dec 27, 2013 | Supplement 20Labeling · Standard review | Approved | None posted |
| Dec 27, 2011 | Supplement 19Labeling | Approved | None posted |
| Jul 27, 2011 | Supplement 15Labeling | Approved | None posted |
| Jun 24, 2011 | Supplement 17Labeling | Approved | None posted |
| Aug 18, 2010 | Supplement 14Labeling | Approved | None posted |
| Jul 2, 2010 | Supplement 11Labeling | Approved | None posted |
| Jul 22, 2009 | Supplement 5Labeling | Approved | None posted |
| Nov 17, 2008 | Supplement 3Labeling | Approved | None posted |
| Mar 26, 2008 | Supplement 2Labeling | Approved | None posted |
| Jun 29, 2007 | 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
