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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 204724

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NDA 204724 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 204724

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Glenmark Pharms Ltd
Ingredient:	sevelamer hydrochloride
Patents:	0

Pharmacology for NDA: 204724

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 204724

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	204724	ANDA	Major Pharmaceuticals	0904-7209	0904-7209-06	50 BLISTER PACK in 1 CARTON (0904-7209-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	204724	ANDA	Cardinal Health 107, LLC	55154-2647	55154-2647-0	10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Feb 8, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Feb 8, 2019	TE:	AB	RLD:	No

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