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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203560
Company: ACTAVIS ELIZABETH

Products on ANDA 203560

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 203560

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2016	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203560Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203560Orig1s000ltr.pdf

Labels for ANDA 203560

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203560Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 203560

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	GLENMARK SPECLT
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
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	207124	TEVA PHARMS USA
DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209426	TORRENT
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	GLENMARK SPECLT
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
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	207124	TEVA PHARMS USA
DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209426	TORRENT
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	GLENMARK SPECLT
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
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	207124	TEVA PHARMS USA
DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	209426	TORRENT
EXJADE	DEFERASIROX	500MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	021882	NOVARTIS

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