Details for New Drug Application (NDA): 208843
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NDA 208843 describes SIKLOS, which is a drug marketed by Theravia and is included in one NDA. It is available from one supplier. Additional details are available on the SIKLOS profile page.
The generic ingredient in SIKLOS 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 SIKLOS 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 208843
| Tradename: | SIKLOS |
| Applicant: | Theravia |
| Ingredient: | hydroxyurea |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208843
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIKLOS | hydroxyurea | TABLET;ORAL | 208843 | NDA | Medunik | 71770-105 | 71770-105-60 | 1 BOTTLE in 1 CARTON (71770-105-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| SIKLOS | hydroxyurea | TABLET;ORAL | 208843 | NDA | Medunik | 71770-120 | 71770-120-30 | 1 BOTTLE in 1 CARTON (71770-120-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE FREQUENCY OF PAINFUL CRISES AND TO REDUCE THE NEED FOR BLOOD TRANSFUSIONS IN PEDIATRIC PATIENTS, 2 YEARS OF AGE AND OLDER, WITH SICKLE CELL ANEMIA WITH RECURRENT MODERATE TO SEVERE PAINFUL CRISIS | ||||||||
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