Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213239
Company: HIKMA

Products on ANDA 213239

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEFERIPRONE	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	AB	No	No
DEFERIPRONE	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213239

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2021	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
11/22/2023	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/14/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
10/21/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213239

DEFERIPRONE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERIPRONE	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	No	AB	213239	HIKMA
DEFERIPRONE	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	No	AB	208800	TARO
FERRIPROX	DEFERIPRONE	500MG	TABLET;ORAL	Prescription	Yes	AB	021825	CHIESI

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEFERIPRONE	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	No	AB	213239	HIKMA
DEFERIPRONE	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	No	AB	208800	TARO
FERRIPROX	DEFERIPRONE	1GM	TABLET;ORAL	Prescription	Yes	AB	021825	CHIESI