Last Updated: November 5, 2026

Details for New Drug Application (NDA): 213145

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NDA 213145 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 213145

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

Pharmacology for NDA: 213145

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 213145

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER HYDROCHLORIDE	sevelamer hydrochloride	TABLET;ORAL	213145	ANDA	Lupin Pharmaceuticals, Inc.	70748-173	70748-173-26	180 TABLET in 1 BOTTLE (70748-173-26)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jun 16, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jun 16, 2021	TE:	AB	RLD:	No

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