Manages mild to moderate pain. NDA 204957, held by B Braun Medical. Acetaminophen.
As of Nov 14, 2026, NDA 204957 (Acetaminophen), held by B Braun Medical, was first approved by FDA on Feb 18, 2021, with 0 approved supplements and 3 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 |
|---|---|---|---|
| Feb 18, 2021 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Apr 24, 2020 | AcetaminophenFacility Inspections | Approved |
| Mar 27, 2019 | AcetaminophenFacility Inspections | Approved |
| Sep 28, 2017 | AcetaminophenFacility Inspections | Approved |
| Acetaminophen500MG/50ML (10MG/ML) · solution;intravenous | Acetaminophen | RxReference drug |
| Acetaminophen1GM/100ML (10MG/ML) · solution;intravenous | Acetaminophen | RxReference 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
