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As of Nov 13, 2026, ANDA 214331 (Acetaminophen), held by Baxter Hlthcare Corp, was first approved by FDA on Sep 17, 2021, with 0 approved supplements and 0 published complete response letters.
First approved: Sep 17, 2021
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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
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
