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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211824
Company: ALEMBIC

Products on ANDA 211824

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	AB	No	No
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	AB	No	No
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211824

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/2020	ORIG-2	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211824Orig1s000ltr.pdf
11/20/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211824Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/12/2023	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211824

DEFERASIROX

TABLET;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	90MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	90MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

TABLET;ORAL; 360MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	360MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	360MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

TABLET;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	208697	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211824	ALEMBIC
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	210555	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	214341	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	214474	AUROBINDO PHARMA LTD
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	212669	CHARTWELL RX
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	210945	MSN
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211395	MYLAN
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	212995	PIRAMAL HLTHCARE UK
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211641	SUN PHARM
DEFERASIROX	DEFERASIROX	180MG	TABLET;ORAL	Prescription	No	AB	211383	ZYDUS PHARMS
JADENU	DEFERASIROX	180MG	TABLET;ORAL	Prescription	Yes	AB	206910	NOVARTIS PHARMS CORP

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