Details for New Drug Application (NDA): 090978

NDA 090978 describes LANTHANUM CARBONATE, which is a drug marketed by Barr, Invagen Pharms, and Natco Pharma Ltd, and is included in three NDAs. It is available from four suppliers. Additional details are available on the LANTHANUM CARBONATE profile page.

The generic ingredient in LANTHANUM CARBONATE is lanthanum carbonate. There are nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.

Summary for 090978

Tradename:	LANTHANUM CARBONATE
Applicant:	Natco Pharma Ltd
Ingredient:	lanthanum carbonate
Patents:	0

Pharmacology for NDA: 090978

Mechanism of Action

Phosphate Chelating Activity

Suppliers and Packaging for NDA: 090978

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090978	ANDA	Lupin Pharmaceuticals, Inc.	68180-819	68180-819-42	2 BOTTLE in 1 PACKAGE (68180-819-42) / 45 TABLET, CHEWABLE in 1 BOTTLE
LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	090978	ANDA	Lupin Pharmaceuticals, Inc.	68180-820	68180-820-46	6 BOTTLE in 1 PACKAGE (68180-820-46) / 15 TABLET, CHEWABLE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Aug 11, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 750MG BASE
Approval Date:	Aug 11, 2017	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 1GM BASE
Approval Date:	Aug 11, 2017	TE:	AB	RLD:	No

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