Drugs@FDA: FDA Approved Drug Products

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

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 SHIRE LLC
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 SHIRE LLC
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 SHIRE LLC
LANTHANUM CARBONATE LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE;ORAL Prescription No AB 090978 NATCO PHARMA LTD

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