Manages mild to moderate pain. NDA 206968, held by Hikma. Acetaminophen.
As of Nov 14, 2026, NDA 206968 (Acetaminophen), held by Hikma, was first approved by FDA on Jun 3, 2022, with 1 approved supplement and 4 published complete response letters.
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older. the management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. the reduction of fever in adult and pediatric patients. Acetaminophen Injection is indicated for the Management of mild to moderate pain in adult and pediatric patients 2 years and older. Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older. Reduction of fever in adult and pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 3, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Dec 22, 2020 | AcetaminophenNonclinical, Product Quality, Identified Issue | Approved |
| Nov 9, 2018 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Nov 15, 2016 | AcetaminophenNonclinical, Facility Inspections | Approved |
| Feb 27, 2015 | AcetaminophenNonclinical, Product Quality, Facility Inspections | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen1GM/100ML (10MG/ML) · solution;intravenous | Acetaminophen | RxReference drug |
| May 28, 2024 | Supplement 3Labeling · Standard review | Approved | |
| Jun 3, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
