← FDA Drug Approvals (Drugs@FDA)
KIMYRSA
NDA · New Drug Application · Sponsor: MELINTA THERAP · Approved 2021-03-12
Drug application
- FDA Application #
NDA214155- Application type
- New Drug Application
- Brand name
- KIMYRSA
- Generic name
- ORITAVANCIN DIPHOSPHATE
- Active ingredients
- ORITAVANCIN DIPHOSPHATE
- Dosage form
- POWDER
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- MELINTA THERAP
- Manufacturer
- Melinta Therapeutics, LLC
- First approval
- 2021-03-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown