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Last Updated: April 3, 2026

Details for New Drug Application (NDA): 217319

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NDA 217319 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 217319

Tradename:	SEVELAMER CARBONATE
Applicant:	Chartwell Rx
Ingredient:	sevelamer carbonate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	800MG/PACKET
Approval Date:	Mar 2, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	2.4GM/PACKET
Approval Date:	Mar 2, 2023	TE:	AB	RLD:	No

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