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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090978

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NDA 090978 describes LANTHANUM CARBONATE, which is a drug marketed by Natco Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the LANTHANUM CARBONATE profile page.

The generic ingredient in LANTHANUM CARBONATE is lanthanum carbonate. There are eight drug master file entries for this compound. Five 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
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090978
Mechanism of ActionPhosphate 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 (68180-819-52)
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 (68180-820-53)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 500MG BASE
Approval Date:Aug 11, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 750MG BASE
Approval Date:Aug 11, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrengthEQ 1GM BASE
Approval Date:Aug 11, 2017TE:ABRLD:No

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