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. It is available from one supplier. Additional details are available on the RENAGEL profile page.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Eight 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

Suppliers and Packaging for NDA: 021179

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RENAGEL	sevelamer hydrochloride	TABLET;ORAL	021179	NDA AUTHORIZED GENERIC	Winthrop U.S.	0955-1048	0955-1048-18	180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)

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

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