Cinacalcet Hydrochloride

For chronic kidney disease (CKD) on dialysis. ANDA 209403, held by Hetero Labs Ltd V. Cinacalcet Hydrochloride.

As of Nov 15, 2026, ANDA 209403 (Cinacalcet Hydrochloride), held by Hetero Labs Ltd V, was first approved by FDA on Oct 7, 2020, with 0 approved supplements and 0 published complete response letters.

First approved: Oct 7, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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).
Severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy. 1.1 Secondary Hyperparathyroidism Cinacalcet tablets are indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Oct 7, 2020	Original application	Approved	None posted

Products

3 strengths and forms


Cinacalcet HydrochlorideEQ 30MG BASE · tablet;oral	Cinacalcet Hydrochloride	Discontinued
Cinacalcet HydrochlorideEQ 60MG BASE · tablet;oral	Cinacalcet Hydrochloride	Discontinued
Cinacalcet HydrochlorideEQ 90MG BASE · tablet;oral	Cinacalcet Hydrochloride	Discontinued

Identifiers

Application: ANDA 209403
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd

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