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. Fifteen 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. Fifteen 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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1GM | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
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