ANDA 216999, held by Bionpharma. Acetaminophen; Ibuprofen.
As of Nov 15, 2026, ANDA 216999 (Acetaminophen And Ibuprofen), held by Bionpharma, was first approved by FDA on Aug 1, 2023, with 0 approved supplements and 0 published complete response letters.
Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps muscular aches minor pain of arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2023 | 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
