NDA 218771, held by Almaject. Teriparatide.
As of Nov 13, 2026, NDA 218771 (Teriparatide), held by Almaject, was first approved by FDA on Jun 4, 2024, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 2024 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Teriparatide0.56MG/2.24ML (0.25MG/ML) · solution;subcutaneous | Teriparatide | RxReference drug |
| Aug 3, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Jan 23, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Jun 4, 2024 | Original applicationNew formulation or manufacturer · Standard review | 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
