ANDA 78569, held by Sun Pharm Inds Ltd. Acetaminophen.
As of Nov 13, 2026, ANDA 78569 (Acetaminophen), held by Sun Pharm Inds Ltd, was first approved by FDA on Dec 14, 2011, with 2 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 |
|---|---|---|---|
| Dec 14, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen650MG · tablet, extended release;oral | Acetaminophen | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2015 | Supplement 1Labeling | Approved | None posted |
| Aug 10, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 14, 2011 | Original application | Approved | None posted |
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
