Cinacalcet Hydrochloride

ANDA 210548, held by Lupin. Cinacalcet Hydrochloride.

As of Nov 15, 2026, ANDA 210548 (Cinacalcet Hydrochloride), held by Lupin, was first approved by FDA on Jun 28, 2019, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 28, 2019
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 28, 2019	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

All 2 submissions, including labeling and manufacturing supplements


Dec 4, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jun 28, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 210548
Drugs@FDA: Overview at FDA
Company: Lupin

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