← FDA Drug Approvals (Drugs@FDA)
TOLSURA
NDA · New Drug Application · Sponsor: MAYNE PHARMA · Approved 2018-12-11
Drug application
- FDA Application #
NDA208901- Application type
- New Drug Application
- Brand name
- TOLSURA
- Generic name
- ITRACONAZOLE
- Active ingredients
- ITRACONAZOLE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MAYNE PHARMA
- Manufacturer
- Mayne Pharma Commercial LLC
- First approval
- 2018-12-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown