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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 016295

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NDA 016295 describes HYDREA, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from two suppliers. Additional details are available on the HYDREA profile page.

The generic ingredient in HYDREA is hydroxyurea. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

Summary for 016295

Tradename:	HYDREA
Applicant:	Waylis Therap
Ingredient:	hydroxyurea
Patents:	0

Pharmacology for NDA: 016295

Medical Subject Heading (MeSH) Categories for 016295

Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 016295

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-402	61269-402-60	60 CAPSULE in 1 BOTTLE (61269-402-60)
DROXIA	hydroxyurea	CAPSULE;ORAL	016295	NDA	H2-Pharma LLC	61269-403	61269-403-60	60 CAPSULE in 1 BOTTLE (61269-403-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Feb 25, 1998	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	300MG
Approval Date:	Feb 25, 1998	TE:		RLD:	Yes

Expired US Patents for NDA 016295

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	HYDREA	hydroxyurea	CAPSULE;ORAL	016295-001	Approved Prior to Jan 1, 1982	3,968,249	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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