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Last Updated: December 22, 2024

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, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Shandong Xinhua, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-four NDAs. It is available from twenty-four 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. Twenty-six 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

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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