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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 four suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the RENAGEL profile page.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-one drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.

Summary for NDA: 021179

Tradename:
RENAGEL
Applicant:
Genzyme
Ingredient:
sevelamer hydrochloride
Patents:1
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 021179

Mechanism of ActionPhosphate Chelating Activity

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 Atlantic Biologicals Corps 17856-0021 17856-0021-2 1 TABLET in 1 POUCH (17856-0021-2)
RENAGEL
sevelamer hydrochloride
TABLET;ORAL 021179 NDA Cardinal Health 55154-9726 55154-9726-0 10 POUCH in 1 BAG (55154-9726-0) > 1 TABLET in 1 POUCH

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jul 12, 2000TE:RLD:No
Patent:6,733,780Patent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 12, 2000TE:RLD:Yes
Patent:6,733,780Patent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021179

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20005,496,545► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-001Jul 12, 20007,459,151► subscribe
Genzyme
RENAGEL
sevelamer hydrochloride
TABLET;ORAL021179-002Jul 12, 20007,459,151► subscribe
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