← FDA Drug Approvals (Drugs@FDA)
HYDROXYUREA
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: QILU · Approved 2024-03-06
Drug application
- FDA Application #
ANDA218021- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- HYDROXYUREA
- Generic name
- HYDROXYUREA
- Active ingredients
- HYDROXYUREA
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- QILU
- Manufacturer
- Somerset Therapeutics, LLC
- First approval
- 2024-03-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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