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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216593


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NDA 216593 describes XROMI, which is a drug marketed by Nova Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the XROMI profile page.

The generic ingredient in XROMI 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 216593
Tradename:XROMI
Applicant:Nova Labs Ltd
Ingredient:hydroxyurea
Patents:0
Pharmacology for NDA: 216593
Suppliers and Packaging for NDA: 216593
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XROMI hydroxyurea SOLUTION;ORAL 216593 NDA Nova Laboratories, Ltd. 62484-0015 62484-0015-5 1 BOTTLE in 1 CARTON (62484-0015-5) / 148 mL in 1 BOTTLE (62484-0015-4)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Apr 4, 2024TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 4, 2027
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Apr 4, 2031
Regulatory Exclusivity Use:TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS AGED 6 MONTHS OF AGE TO LESS THAN 2 YEARS, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISES

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