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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218966

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NDA 218966 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Navinta Llc, and Rising, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.

The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

Summary for 218966

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Navinta Llc
Ingredient:	sevelamer hydrochloride
Patents:	0

Pharmacology for NDA: 218966

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 218966

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	218966	ANDA	Zydus Pharmaceuticals USA Inc.	70710-2058	70710-2058-8	180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Feb 3, 2025	TE:	AB	RLD:	No

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