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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208843

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SIKLOS (HYDROXYUREA)
100MG
Marketing Status: Prescription
Active Ingredient: HYDROXYUREA
Proprietary Name: SIKLOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208843
Product Number: 001
Approval Date: Dec 21, 2017
Applicant Holder Full Name: ADDMEDICA SAS
Marketing Status:  Prescription
Patent and Exclusivity Information
SIKLOS (HYDROXYUREA)
1GM
Marketing Status: Prescription
Active Ingredient: HYDROXYUREA
Proprietary Name: SIKLOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208843
Product Number: 002
Approval Date: Dec 21, 2017
Applicant Holder Full Name: ADDMEDICA SAS
Marketing Status:  Prescription
Patent and Exclusivity Information
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