← FDA Drug Approvals (Drugs@FDA)
ONMEL
NDA · New Drug Application · Sponsor: SEBELA IRELAND LTD · Approved 2010-04-29
Drug application
- FDA Application #
NDA022484- Application type
- New Drug Application
- Brand name
- ONMEL
- Generic name
- Itraconazole
- Active ingredients
- ITRACONAZOLE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- SEBELA IRELAND LTD
- First approval
- 2010-04-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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