Relieves mild to moderate pain. ANDA 215548, held by Misemer. Fenoprofen Calcium.
As of Nov 15, 2026, ANDA 215548 (Fenoprofen Calcium), held by Misemer, was first approved by FDA on May 16, 2023, with 0 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE FENOPROFEN CALCIUM is indicated for: Relief of mild to moderate pain in adults. Relief of the signs and symptoms of rheumatoid arthrites. Relief of the signs and symptoms of osteoarthritis. FENOPROFEN CALCIUM is a nonsteroidal anti-inflammatory drug
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2023 | Original application | Approved | None posted |
| Fenoprofen CalciumEQ 200MG BASE · capsule;oral | Fenoprofen Calcium | Rx |
| Fenoprofen CalciumEQ 300MG BASE · capsule;oral | Fenoprofen Calcium | Rx |
| Fenoprofen CalciumEQ 400MG BASE · capsule;oral | Fenoprofen Calcium | Rx |
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
