ANDA 208569, held by Teva Pharms USA. Teriparatide.
As of Nov 15, 2026, ANDA 208569 (Teriparatide), held by Teva Pharms USA, was first approved by FDA on Nov 16, 2023, with 1 approved supplement and 0 published complete response letters.
Teriparatide Injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide Injection reduces the risk of vertebral and nonvertebral fractures. To increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 2023 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Teriparatide0.56MG/2.24ML (0.25MG/ML) · solution;subcutaneous | Teriparatide | Rx |
| Nov 6, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Original application | Approved |
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
