ANDA 215486, held by Pharmazone. Acetaminophen.
As of Nov 13, 2026, ANDA 215486 (Acetaminophen), held by Pharmazone, was first approved by FDA on Aug 25, 2021, with 0 approved supplements and 0 published complete response letters.
Uses 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen650MG · tablet, extended release;oral | Acetaminophen | OTC |
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
