NDC 66992-128

OTOVEL

Ciprofloxacin And Fluocinolone Acetonide

OTOVEL is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Wraser, Llc. The primary component is Ciprofloxacin; Fluocinolone Acetonide.

Product ID66992-128_cd9ca29d-6de4-5ed5-e053-2995a90acf32
NDC66992-128
Product TypeHuman Prescription Drug
Proprietary NameOTOVEL
Generic NameCiprofloxacin And Fluocinolone Acetonide
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2021-10-04
Marketing CategoryNDA /
Application NumberNDA208251
Labeler NameWraSer, LLC
Substance NameCIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active Ingredient Strength1 mg/.25mL; mg/.25mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 66992-128-14

1 POUCH in 1 CARTON (66992-128-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2021-10-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "OTOVEL" or generic name "Ciprofloxacin And Fluocinolone Acetonide"

NDCBrand NameGeneric Name
24338-080OTOVEL(ciprofloxacin and fluocinolone acetonide)
66992-128OTOVELciprofloxacin and fluocinolone acetonide
42195-128Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonide
52536-080Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonide

Trademark Results [OTOVEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OTOVEL
OTOVEL
86875555 5381190 Live/Registered
LABORATORIOS SALVAT, S.A.
2016-01-14

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