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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215998

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NDA 215998 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma Intl, Torrent, Amneal Pharms Co, Arthur Grp, Epic Pharma Llc, Impax Labs Inc, Micro Labs, Navinta Llc, Rising, Shandong Xinhua, Strides Pharma, and Zydus Pharms, and is included in twenty-six NDAs. It is available from thirty-one suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.

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

Summary for 215998

Tradename:	SEVELAMER CARBONATE
Applicant:	Shandong Xinhua
Ingredient:	sevelamer carbonate
Patents:	0

Pharmacology for NDA: 215998

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 215998

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	215998	ANDA	Shandong Xinhua Pharmaceutical Co., Ltd.	58624-5001	58624-5001-4	18399 TABLET, FILM COATED in 1 CARTON (58624-5001-4)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 24, 2024	TE:	AB	RLD:	No

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