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Last Updated: January 1, 2026

Details for New Drug Application (NDA): 219931

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NDA 219931 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 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-two suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for 219931

Tradename:	SEVELAMER CARBONATE
Applicant:	Navinta Llc
Ingredient:	sevelamer carbonate
Patents:	0

Pharmacology for NDA: 219931

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 219931

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	219931	ANDA	Navinta LLC	68475-010	68475-010-01	30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01)
SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	219931	ANDA	Navinta LLC	68475-010	68475-010-02	270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 27, 2025	TE:	AB	RLD:	No

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