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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
Merck
US Army
Teva
Accenture
Express Scripts
Colorcon
Baxter
Medtronic

Generated: November 25, 2017

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 Labs Inc, Barr, 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 075143

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 075143

Ingredient-typeUrea

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 0555-0882-02 100 CAPSULE in 1 BOTTLE (0555-0882-02)
HYDROXYUREA
hydroxyurea
CAPSULE;ORAL 075143 ANDA AvKARE, Inc. 42291-321 42291-321-01 100 CAPSULE in 1 BOTTLE (42291-321-01)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Deloitte
Cerilliant
Colorcon
Queensland Health
Medtronic
Novartis
Moodys
Argus Health
Merck
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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