ANDA 76288, held by Natco Pharma USA. Risperidone.
As of Nov 14, 2026, ANDA 76288 (Risperidone), held by Natco Pharma USA, was first approved by FDA on Sep 15, 2008, with 12 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 |
| Oct 1, 2021 | Supplement 20Labeling · Standard review | Approved | None posted |
| Nov 3, 2020 | Supplement 19Labeling · Standard review | Approved | None posted |
| Nov 3, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Nov 3, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 3, 2020 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 3, 2020 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jan 5, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 21, 2013 | Supplement 10Labeling · Standard review | Approved | None posted |
| Feb 13, 2012 | Supplement 7Labeling | Approved | None posted |
| Apr 22, 2011 | Supplement 5Labeling | Approved | None posted |
| Dec 29, 2010 | Supplement 3Labeling | Approved | None posted |
| Apr 27, 2010 | Supplement 2Labeling | 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
