Manages mild to moderate pain. NDA 204767, held by Fresenius Kabi USA. Acetaminophen.
As of Nov 13, 2026, NDA 204767 (Acetaminophen), held by Fresenius Kabi USA, was first approved by FDA on Oct 28, 2015, with 3 approved supplements and 0 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 2 years and older. 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 2 years and older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2015 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen1GM/100ML (10MG/ML) · solution;intravenous | Acetaminophen | Rx |
| Jul 28, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jun 23, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Nov 13, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Oct 28, 2015 | 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
