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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 203422

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NDA 203422 describes CINACALCET HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Piramal, Rising, Stevens J, Strides Pharma, Sun Pharm, and Watson Labs Teva, and is included in fourteen NDAs. It is available from fifteen suppliers. Additional details are available on the CINACALCET HYDROCHLORIDE profile page.

The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

Summary for 203422

Tradename:	CINACALCET HYDROCHLORIDE
Applicant:	Rising
Ingredient:	cinacalcet hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 203422

Calcimimetic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 30MG BASE
Approval Date:	Oct 16, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 60MG BASE
Approval Date:	Oct 16, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 90MG BASE
Approval Date:	Oct 16, 2018	TE:		RLD:	No

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