Prevents postmenopausal osteoporosis. ANDA 200296, held by Aurobindo Pharma Ltd. Risedronate Sodium.
As of Nov 15, 2026, ANDA 200296 (Risedronate Sodium), held by Aurobindo Pharma Ltd, was first approved by FDA on Nov 30, 2015, with 2 approved supplements and 0 published complete response letters.
Risedronate sodium tablets are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis Treatment to increase bone mass in men with osteoporosis Treatment and prevention of glucocorticoid-induced osteoporosis Treatment of Paget’s disease Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use. 1.1 Postmenopausal Osteoporosis Risedronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2015 | Original application | Approved | None posted |
| Risedronate Sodium5MG · tablet;oral | Risedronate Sodium | Rx |
| Risedronate Sodium30MG · tablet;oral | Risedronate Sodium | Rx |
| Risedronate Sodium35MG · tablet;oral | Risedronate Sodium | Rx |
| Jun 8, 2026 | Supplement 8Labeling · Standard review | Approved | None posted |
| Aug 6, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 30, 2015 | 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
