ANDA 91537, held by Natco Pharma USA. Risperidone.
As of Nov 13, 2026, ANDA 91537 (Risperidone), held by Natco Pharma USA, was first approved by FDA on Mar 30, 2011, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2011 | Original application | Approved | None posted |
| Risperidone0.5MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Risperidone1MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Risperidone2MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Risperidone3MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Risperidone4MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Risperidone0.25MG · tablet, orally disintegrating;oral | Risperidone | Discontinued |
| Nov 2, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 2, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 28, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Oct 28, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 28, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 22, 2013 | Supplement 3Labeling | Approved | None posted |
| Feb 12, 2013 | Supplement 2Manufacturing | Approved | None posted |
| Dec 13, 2012 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 13, 2012 | Supplement 1Labeling | Approved | None posted |
| Mar 30, 2011 | 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
