Details for New Drug Application (NDA): 216593
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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 |
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: | RX | Dosage: | SOLUTION;ORAL | Strength | 100MG/ML | ||||
Approval Date: | Apr 4, 2024 | TE: | 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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