Last Updated: September 28, 2026

Details for New Drug Application (NDA): 021179

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NDA 021179 describes RENAGEL, which is a drug marketed by Genzyme and is included in two NDAs. Additional details are available on the RENAGEL profile page.

The generic ingredient in RENAGEL 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 021179

Tradename:	RENAGEL
Applicant:	Genzyme
Ingredient:	sevelamer hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Jul 12, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Jul 12, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021179

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-002	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
Genzyme	RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179-001	Jul 12, 2000	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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