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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 202329


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NDA 202329 describes LANTHANUM CARBONATE, which is a drug marketed by Alkem Labs Ltd, Barr, Invagen Pharms, and Natco Pharma Ltd, and is included in four NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the lanthanum carbonate profile page.
Summary for 202329
Tradename:LANTHANUM CARBONATE
Applicant:Alkem Labs Ltd
Ingredient:lanthanum carbonate
Patents:0
Pharmacology for NDA: 202329
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 202329
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANTHANUM CARBONATE lanthanum carbonate TABLET, CHEWABLE;ORAL 202329 ANDA Ascend Laboratories, LLC 67877-256 67877-256-90 2 BOTTLE in 1 CARTON (67877-256-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (67877-256-45)
LANTHANUM CARBONATE lanthanum carbonate TABLET, CHEWABLE;ORAL 202329 ANDA Ascend Laboratories, LLC 67877-257 67877-257-90 6 BOTTLE in 1 CARTON (67877-257-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (67877-257-15)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 500MG BASE
Approval Date:Mar 13, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 750MG BASE
Approval Date:Mar 13, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 1GM BASE
Approval Date:Mar 13, 2025TE:ABRLD:No

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