ANDA 77953, held by Apotex Inc. Risperidone.
As of Nov 13, 2026, ANDA 77953 (Risperidone), held by Apotex Inc, was first approved by FDA on Sep 15, 2008, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2008 | Original application | Approved | None posted |
| Risperidone0.25MG · tablet;oral | Risperidone | Discontinued |
| Risperidone0.5MG · tablet;oral | Risperidone | Discontinued |
| Risperidone1MG · tablet;oral | Risperidone | Discontinued |
| Risperidone2MG · tablet;oral | Risperidone | Discontinued |
| Risperidone3MG · tablet;oral | Risperidone | Discontinued |
| Risperidone4MG · tablet;oral | Risperidone | Discontinued |
| Sep 11, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 28, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 28, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 28, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 28, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Aug 28, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 23, 2014 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 18, 2013 | Supplement 6Labeling | Approved | None posted |
| Jan 5, 2012 | Supplement 7Labeling | Approved | None posted |
| May 27, 2011 | Supplement 4Labeling | Approved | None posted |
| Apr 27, 2010 | Supplement 3Labeling | Approved | None posted |
| Sep 15, 2008 | 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
