← FDA Drug Approvals (Drugs@FDA)
OTOVEL
NDA · New Drug Application · Sponsor: LAB SALVAT · Approved 2016-04-29
Drug application
- FDA Application #
NDA208251
- Application type
- New Drug Application
- Brand name
- OTOVEL
- Generic name
- Ciprofloxacin Hydrochloride
- Active ingredients
- CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE
- Dosage form
- SOLUTION/DROPS
- Route
- OTIC
- Marketing status
- Prescription
- Sponsor
- LAB SALVAT
- First approval
- 2016-04-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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