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As of Nov 13, 2026, ANDA 211544 (Acetaminophen), held by Granules, was first approved by FDA on Apr 16, 2019, with 1 approved supplement and 0 published complete response letters.
First approved: Apr 16, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
USES For Arthritis Pain label
temporarily relieves minor aches and pains due to:
minor pain of arthritis
muscular aches
backache
premenstrual and menstrual cramps
the common cold
headache
toothache
temporarily reduces fever For Muscle Aches & Pain label
temporarily relieves minor aches and pains due to:
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
