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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214559
Company: AUCTA

Products on ANDA 214559

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214559

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214559

DEFERASIROX

GRANULE;ORAL; 90MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

GRANULE;ORAL; 180MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

GRANULE;ORAL; 360MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	213374	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	216229	ANNORA PHARMA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214559	AUCTA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214180	TEVA PHARMS USA
JADENU SPRINKLE	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

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