NDA 206610, held by Rising. Acetaminophen.
As of Nov 14, 2026, NDA 206610 (Acetaminophen), held by Rising, was first approved by FDA on Jan 15, 2021, with 0 approved supplements and 5 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Jun 6, 2019 | AcetaminophenFacility Inspections | Approved |
| Dec 6, 2017 | NDA 206610Nonclinical | Approved |
| Feb 1, 2017 | AcetaminophenNonclinical | Approved |
| Mar 10, 2016 | AcetaminophenNonclinical | Approved |
| Feb 27, 2015 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen1GM/VIAL · powder;intravenous | Acetaminophen | DiscontinuedReference drug |
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
