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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090978
Company: NATCO PHARMA LTD

Products on ANDA 090978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/20/2022	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/20/2022	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090978

LANTHANUM CARBONATE

TABLET, CHEWABLE;ORAL; EQ 500MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 500MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

TABLET, CHEWABLE;ORAL; EQ 750MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 750MG BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

TABLET, CHEWABLE;ORAL; EQ 1GM BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FOSRENOL	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	Yes	AB	021468	TAKEDA PHARMS USA
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090977	BARR
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	206868	INVAGEN PHARMS
LANTHANUM CARBONATE	LANTHANUM CARBONATE	EQ 1GM BASE	TABLET, CHEWABLE;ORAL	Prescription	No	AB	090978	NATCO PHARMA LTD

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