An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 218021
Company: QILU

Products on ANDA 218021

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 218021

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218021

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

Top