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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
Johnson and Johnson

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075143

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NDA 075143 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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 075143
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 075143
Suppliers and Packaging for NDA: 075143
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075143 ANDA Teva Pharmaceuticals USA Inc 0555-0882 N 0555-0882-02
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075143 ANDA AvKARE, Inc. 42291-321 N 42291-321-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Oct 16, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength250MG
Approval Date:Sep 21, 2000TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Argus Health
US Army

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