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Last Updated: March 28, 2024

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, Leading, Par Pharm, and Roxane, and is included in six NDAs. It is available from ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 075143
Tradename:HYDROXYUREA
Applicant:Barr
Ingredient:hydroxyurea
Patents:0
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 0555-0882-02 100 CAPSULE in 1 BOTTLE (0555-0882-02)
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075143 ANDA AvKARE 42291-321 42291-321-01 100 CAPSULE in 1 BOTTLE (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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