FDA.reportPublic FDA data

Application 208251

Type
NDA
Sponsor
LABORATORIOS SALVAT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTOVELCIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDESOLUTION/DROPS;OTICEQ 0.3% BASE;0.025%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-080OTOVEL(ciprofloxacin and fluocinolone acetonide)Arbor PharmaceuticalsNDACurrent
24338-080OTOVEL(ciprofloxacin and fluocinolone acetonide)Arbor PharmaceuticalsNDACurrent
24338-080OTOVEL(ciprofloxacin and fluocinolone acetonide)Arbor PharmaceuticalsNDACurrent
42195-128Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonideXspire Pharma, LLCNDACurrent
42195-128Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonideXspire Pharma, LLCNDACurrent
52536-080Ciprofloxacin and Fluocinolone Acetonideciprofloxacin and fluocinolone acetonideWilshire PharmaceuticalsNDACurrent
66992-128OTOVELciprofloxacin and fluocinolone acetonideWraSer LLCNDACurrent
66992-128OTOVELciprofloxacin and fluocinolone acetonideWraSer, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50126ORIG2017-10-20
40629ORIG2016-05-03
10651ORIG2016-05-02
52572ORIG1900-01-01
52571ORIG1900-01-01
52570ORIG1900-01-01