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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 206883

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NDA 206883 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 206883

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	sevelamer hydrochloride
Patents:	0

Pharmacology for NDA: 206883

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 206883

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	206883	ANDA	Macleods Pharmaceuticals Limited	33342-241	33342-241-65	360 TABLET, FILM COATED in 1 BOTTLE (33342-241-65)
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	206883	ANDA	Macleods Pharmaceuticals Limited	33342-242	33342-242-07	30 TABLET, FILM COATED in 1 BOTTLE (33342-242-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	May 26, 2023	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	May 26, 2023	TE:	AB	RLD:	No

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