ANDA 214836, held by L Perrigo Co. Acetaminophen; Ibuprofen.
As of Nov 15, 2026, ANDA 214836 (Acetaminophen And Ibuprofen), held by L Perrigo Co, was first approved by FDA on Feb 28, 2023, with 3 approved supplements and 0 published complete response letters.
Uses
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetaminophen And Ibuprofen250MG;125MG · tablet;oral | Acetaminophen; Ibuprofen | OTC |
| Oct 22, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 22, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 22, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 28, 2023 | Original application | Approved |
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
