← FDA Drug Approvals (Drugs@FDA)
SIKLOS
NDA · New Drug Application · Sponsor: THERAVIA · Approved 2017-12-21
Drug application
- FDA Application #
NDA208843
- Application type
- New Drug Application
- Brand name
- SIKLOS
- Generic name
- HYDROXYUREA
- Active ingredients
- HYDROXYUREA
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- THERAVIA
- Manufacturer
- Medunik
- First approval
- 2017-12-21
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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