Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213438
Company: LEADING

Products on ANDA 213438

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213438

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/08/2020	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
04/09/2024	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
04/09/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213438

HYDROXYUREA

CAPSULE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	Yes	AB	016295	WAYLIS THERAP
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	075143	BARR
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	213438	LEADING
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	075340	PH HEALTH
HYDROXYUREA	HYDROXYUREA	500MG	CAPSULE;ORAL	Prescription	No	AB	218021	QILU