← FDA Drug Approvals (Drugs@FDA)
ORBACTIV
NDA · New Drug Application · Sponsor: MELINTA THERAP · Approved 2014-08-06
Drug application
- FDA Application #
NDA206334
- Application type
- New Drug Application
- Brand name
- ORBACTIV
- Generic name
- ORITAVANCIN
- Active ingredients
- ORITAVANCIN DIPHOSPHATE
- Dosage form
- POWDER
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- MELINTA THERAP
- Manufacturer
- Melinta Therapeutics, LLC
- First approval
- 2014-08-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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