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Last Updated: November 22, 2024

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, Endo Operations, Leading, Qilu, and Roxane, and is included in seven NDAs. It is available from twelve 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 075340
Tradename:HYDROXYUREA
Applicant:Endo Operations
Ingredient:hydroxyurea
Patents:0
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 Major Pharmaceuticals 0904-6939 0904-6939-61 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK
HYDROXYUREA hydroxyurea CAPSULE;ORAL 075340 ANDA Endo USA, Inc. 49884-724 49884-724-01 100 CAPSULE in 1 BOTTLE (49884-724-01)

Profile for product number 001

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

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