ANDA 218359, held by Aurobindo Pharma Ltd. Acetaminophen; Ibuprofen.
As of Nov 15, 2026, ANDA 218359 (Acetaminophen And Ibuprofen), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 26, 2024, with 2 approved supplements and 0 published complete response letters.
Uses temporarily relieves minor aches and pains due to: backache muscular aches minor pain of arthritis headache toothache menstrual cramps
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen And Ibuprofen250MG;125MG · tablet;oral | Acetaminophen; Ibuprofen | OTC |
| Jun 10, 2026 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 10, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 26, 2024 | 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
