Last Updated: September 28, 2026

Details for New Drug Application (NDA): 215537

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NDA 215537 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin, Macleods Pharms, 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-three suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.

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

Summary for 215537

Tradename:	SEVELAMER CARBONATE
Applicant:	Micro Labs
Ingredient:	sevelamer carbonate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Feb 7, 2022	TE:	AB	RLD:	No

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