ANDA 90539, held by Teva Pharms. Cinacalcet Hydrochloride.
As of Nov 15, 2026, ANDA 90539 (Cinacalcet Hydrochloride), held by Teva Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 25, 2017 | Original application | Tentative approval |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cinacalcet Hydrochloride90MG ยท tablet; oral | Cinacalcet Hydrochloride | None (tentative approval) |
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
