Last Updated: September 28, 2026

Details for New Drug Application (NDA): 212599

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NDA 212599 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Lupin, Macleods Pharms, Navinta Llc, and Rising, and is included in six NDAs. It is available from nine suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.

The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

Summary for 212599

Tradename:	SEVELAMER HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	sevelamer hydrochloride
Patents:	0

Pharmacology for NDA: 212599

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 212599

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599	ANDA	Aurobindo Pharma Limited	59651-087	59651-087-36	360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	212599	ANDA	Aurobindo Pharma Limited	59651-088	59651-088-18	180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 11, 2023	TE:	BX	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jul 11, 2023	TE:	BX	RLD:	No

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