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Generated: November 21, 2018

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Details for New Drug Application (NDA): 208843

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NDA 208843 describes SIKLOS, which is a drug marketed by Addmedica Sas 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. Ten suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 208843
Tradename:SIKLOS
Applicant:Addmedica Sas
Ingredient:hydroxyurea
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208843
Ingredient-typeUrea
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 71770-100 71770-100-60 1 BOTTLE in 1 CARTON (71770-100-60) > 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:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 21, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2020
Regulatory Exclusivity Use:NEW PRODUCT
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:RXDosage:TABLET;ORALStrength1GM
Approval Date:Dec 21, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 21, 2020
Regulatory Exclusivity Use:NEW PRODUCT

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