For chronic kidney disease (CKD) on dialysis. ANDA 206125, held by Aurobindo Pharma Ltd. Cinacalcet Hydrochloride.
As of Nov 15, 2026, ANDA 206125 (Cinacalcet Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 8, 2018, with 5 approved supplements and 0 published complete response letters.
Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. Limitations of Use: Cinacalcet tablets are not indicated for use in patients with CKD who are not on dialysis Hypercalcemia in adult patients with Parathyroid Carcinoma (PC). Hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 8, 2018 | Original application | Approved |
| Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Cinacalcet HydrochlorideEQ 90MG BASE · tablet;oral | Cinacalcet Hydrochloride | Rx |
| Mar 23, 2026 | Supplement 10Manufacturing | Approved | None posted |
| Jul 28, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 4, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 4, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 8, 2018 | 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
