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HYDROXYUREA

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 1999-02-24

Drug application

FDA Application #

ANDA075340

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROXYUREA

Generic name

HYDROXYUREA

Active ingredients

HYDROXYUREA

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

PH HEALTH

Manufacturer

Par Health USA, LLC

First approval

1999-02-24

Source

Authoritative

Drugs@FDA application overview

Machine

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