Details for New Drug Application (NDA): 200959

NDA 200959 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Invagen Pharms, Lupin Ltd, Macleods Pharms Ltd, Strides Pharma, Amneal Pharms Co, Arthur Grp, Impax Labs Inc, Micro Labs, Rising, Shandong Xinhua, Sinotherapeutics Inc, and Zydus Pharms, and is included in twenty-four NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for 200959

Tradename:	SEVELAMER CARBONATE
Applicant:	Arthur Grp
Ingredient:	sevelamer carbonate
Patents:	0

Pharmacology for NDA: 200959

Mechanism of Action

Phosphate Chelating Activity

Suppliers and Packaging for NDA: 200959

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	200959	ANDA	TWi Pharmaceuticals, Inc.	24979-186	24979-186-46	270 TABLET, FILM COATED in 1 BOTTLE (24979-186-46)
SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	200959	ANDA	Proficient Rx LP	71205-966	71205-966-67	270 TABLET, FILM COATED in 1 BOTTLE (71205-966-67)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Mar 20, 2018	TE:	AB	RLD:	No

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