Relieves arthritis and esomeprazole magnesium. ANDA 213699, held by Ajanta Pharma Ltd. Esomeprazole Magnesium; Naproxen.
As of Nov 15, 2026, ANDA 213699 (Naproxen And Esomeprazole Magnesium), held by Ajanta Pharma Ltd, was first approved by FDA on Oct 6, 2022, with 2 approved supplements 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 tablet is 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 6, 2022 | 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 22, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 4, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 6, 2022 | 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
