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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 201068

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NDA 201068 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin Ltd, Macleods Pharms Ltd, Navinta Llc, and Rising, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.

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

Summary for 201068

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Rising
Ingredient:	sevelamer hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Dec 14, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Dec 14, 2020	TE:		RLD:	No

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