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Manages mild to moderate pain. ANDA 213255, held by Mylan. Acetaminophen.
As of Nov 14, 2026, ANDA 213255 (Acetaminophen), held by Mylan, was first approved by FDA on Aug 7, 2020, with 0 approved supplements and 0 published complete response letters.
First approved: Aug 7, 2020
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
