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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Queensland Health
Cantor Fitzgerald

Generated: December 18, 2017

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 seven 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. Eight suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

Summary for 075340

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 49884-724-01 100 CAPSULE in 1 BOTTLE (49884-724-01)
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075340 ANDA Cardinal Health 55154-7143 55154-7143-0 10 BLISTER PACK in 1 BAG (55154-7143-0) > 1 CAPSULE in 1 BLISTER PACK

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School

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