Details for New Drug Application (NDA): 206868

NDA 206868 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 206868

Tradename:	LANTHANUM CARBONATE
Applicant:	Invagen Pharms
Ingredient:	lanthanum carbonate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 206868

Mechanism of Action

Phosphate Chelating Activity

Suppliers and Packaging for NDA: 206868

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	206868	ANDA	Cipla USA Inc.	69097-934	69097-934-98	2 BOTTLE in 1 PACKAGE (69097-934-98) / 45 TABLET, CHEWABLE in 1 BOTTLE (69097-934-57)
LANTHANUM CARBONATE	lanthanum carbonate	TABLET, CHEWABLE;ORAL	206868	ANDA	Cipla USA Inc.	69097-935	69097-935-98	6 BOTTLE in 1 PACKAGE (69097-935-98) / 15 TABLET, CHEWABLE in 1 BOTTLE (69097-935-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 500MG BASE
Approval Date:	Jan 24, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 750MG BASE
Approval Date:	Jan 24, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 1GM BASE
Approval Date:	Jan 24, 2022	TE:	AB	RLD:	No

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