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Last Updated: February 24, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204451


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NDA 204451 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Amneal Pharms Co, Impax Labs Inc, Invagen Pharms, Twi Pharms, and Wilshire Pharms Inc, and is included in nine NDAs. It is available from eighteen suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.

The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 204451
Tradename:SEVELAMER CARBONATE
Applicant:Wilshire Pharms Inc
Ingredient:sevelamer carbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204451
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 204451
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 204451 ANDA Wilshire Pharmaceuticals, Inc. 52536-800 52536-800-03 30 TABLET, FILM COATED in 1 BOTTLE (52536-800-03)
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 204451 ANDA Wilshire Pharmaceuticals, Inc. 52536-800 52536-800-27 270 TABLET, FILM COATED in 1 BOTTLE (52536-800-27)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Nov 29, 2018TE:ABRLD:No

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