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FDA NDA · NDA208251

OTOVEL

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APPLICATION
NDA208251
TYPE
NDA
ORIGINAL APPROVAL
2016-04-29
LATEST ACTION
2016-04-29
ROUTE
OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

OTOVEL · ReferencePrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE, FLUOCINOLONE ACETONIDE 0.025% · SOLUTION/DROPS · OTIC

Approval history

2016-04-29Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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