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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075340

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NDA 075340 describes HYDROXYUREA, which is a drug marketed by Barr, Barr Labs Inc, Par Pharm, and Roxane, and is included in five NDAs. It is available from nine suppliers. Additional details are available on the HYDROXYUREA profile page.

The generic ingredient in HYDROXYUREA is hydroxyurea. There are ten drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 075340
Applicant:Par Pharm
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075340
Suppliers and Packaging for NDA: 075340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075340 ANDA Par Pharmaceutical, Inc. 49884-724 N 49884-724-01
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075340 ANDA Cardinal Health 55154-7143 N 55154-7143-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Feb 24, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cantor Fitzgerald
Boehringer Ingelheim
Federal Trade Commission

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