ANDA 208971, held by Zydus Pharms USA Inc. Cinacalcet Hydrochloride.
As of Nov 15, 2026, ANDA 208971 (Cinacalcet Hydrochloride), held by Zydus Pharms USA Inc, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 26, 2018 | Original application | Tentative approval | None posted |
| Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral | Cinacalcet Hydrochloride | None (tentative approval) |
| Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral | Cinacalcet Hydrochloride | None (tentative approval) |
| Cinacalcet HydrochlorideEQ 90MG BASE · 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
