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Last Updated: April 18, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207759

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NDA 207759 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Impax, Amneal Pharms Co, Anxin, Impax Labs Inc, Invagen Pharms, Mylan, Rising, Twi Pharms, and Zydus Pharms, and is included in thirteen NDAs. It is available from seventeen 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 207759
Tradename:SEVELAMER CARBONATE
Applicant:Zydus Pharms
Ingredient:sevelamer carbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207759
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 207759
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207759 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-824 68382-824-10 1000 TABLET, FILM COATED in 1 BOTTLE (68382-824-10)
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207759 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-824 68382-824-27 270 TABLET, FILM COATED in 1 BOTTLE (68382-824-27)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Aug 11, 2020TE:ABRLD:No

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