ANDA 78116, held by Sandoz. Risperidone.
As of Nov 14, 2026, ANDA 78116 (Risperidone), held by Sandoz, was first approved by FDA on Dec 22, 2009, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2009 | Original application | Approved | None posted |
| Risperidone0.5MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| Risperidone1MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| Risperidone2MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| Risperidone3MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| Risperidone4MG · tablet, orally disintegrating;oral | Risperidone | Rx |
| Jan 22, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 1, 2022 | Supplement 16Labeling · Standard review | Approved | None posted |
| Sep 1, 2022 | Supplement 15Labeling · Standard review | Approved | None posted |
| Sep 1, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 1, 2022 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 1, 2022 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 28, 2014 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 10, 2013 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 30, 2012 | Supplement 4Labeling | Approved | None posted |
| Mar 1, 2012 | Supplement 2Labeling | Approved | None posted |
| Feb 21, 2012 | Supplement 3Labeling | Approved | None posted |
| Jun 10, 2011 | Supplement 1Labeling | Approved | None posted |
| Dec 22, 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
