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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016295

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NDA 016295 describes HYDREA, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. Additional details are available on the HYDREA profile page.

The generic ingredient in HYDREA is hydroxyurea. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 016295
Applicant:Bristol Myers Squibb
Formulation / Manufacturing:see details
Pharmacology for NDA: 016295
Suppliers and Packaging for NDA: 016295
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROXIA hydroxyurea CAPSULE;ORAL 016295 NDA E.R. Squibb & Sons, L.L.C. 0003-0830 0003-0830-50 100 CAPSULE in 1 BOTTLE (0003-0830-50)
DROXIA hydroxyurea CAPSULE;ORAL 016295 NDA E.R. Squibb & Sons, L.L.C. 0003-6335 0003-6335-17 60 CAPSULE in 1 BOTTLE (0003-6335-17)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength500MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 25, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG
Approval Date:Feb 25, 1998TE:RLD:Yes

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