Relieves arthritis and esomeprazole magnesium. ANDA 217738, held by Sciegen Pharms. Esomeprazole Magnesium; Naproxen.
As of Nov 15, 2026, ANDA 217738 (Naproxen And Esomeprazole Magnesium), held by Sciegen Pharms, was first approved by FDA on Oct 11, 2023, with 1 approved supplement and 0 published complete response letters.
Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets are indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2023 | Original application | Approved | None posted |
| Naproxen And Esomeprazole MagnesiumEQ 20MG BASE;375MG · tablet, delayed release;oral | Esomeprazole Magnesium; Naproxen | Rx |
| Naproxen And Esomeprazole MagnesiumEQ 20MG BASE;500MG · tablet, delayed release;oral | Esomeprazole Magnesium; Naproxen | Rx |
| Nov 21, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 11, 2023 | 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
