ANDA 219053, held by Taro. Acetaminophen; Ibuprofen.
As of Nov 15, 2026, ANDA 219053 (Acetaminophen And Ibuprofen), held by Taro, was first approved by FDA on Jan 2, 2026, with 0 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 2, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen And Ibuprofen250MG;125MG · tablet;oral | Acetaminophen; Ibuprofen | 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
