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.
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 |
| Formulation / Manufacturing: | see details |
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 | 62484-0015-2 | 1 BOTTLE in 1 CARTON (62484-0015-2) / 100 mL in 1 BOTTLE (62484-0015-1) |
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, 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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