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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216229
Company: ANNORA PHARMA

Products on ANDA 216229

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216229

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2022	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
03/19/2024	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/16/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 216229

DEFERASIROX

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	215137	AUROBINDO PHARMA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	180MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
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	215137	AUROBINDO PHARMA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
JADENU SPRINKLE	DEFERASIROX	360MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

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	215137	AUROBINDO PHARMA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	215026	CIPLA
DEFERASIROX	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	No	AB	214650	MSN
JADENU SPRINKLE	DEFERASIROX	90MG	GRANULE;ORAL	Prescription	Yes	AB	207968	NOVARTIS

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