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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209782
Company: SUN PHARM

Products on ANDA 209782

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209782

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209782Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
11/14/2023	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-9	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2023	SUPPL-3	Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 209782

DEFERASIROX

TABLET, FOR SUSPENSION;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	203560	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210060	ALEMBIC
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210519	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210920	BIONPHARMA
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209433	ICHNOS
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209878	MSN
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209782	SUN PHARM
EXJADE	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	021882	NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	203560	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210060	ALEMBIC
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210519	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210920	BIONPHARMA
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209433	ICHNOS
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209878	MSN
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209782	SUN PHARM
EXJADE	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	021882	NOVARTIS

TABLET, FOR SUSPENSION;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	203560	ACTAVIS ELIZABETH
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210060	ALEMBIC
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210519	ALKEM LABS LTD
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210920	BIONPHARMA
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209433	ICHNOS
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209878	MSN
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209782	SUN PHARM
EXJADE	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	021882	NOVARTIS

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