FDA.reportPublic FDA data

Application 021918

Type
NDA
Sponsor
WRASER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETRAXALCIPROFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OTICEQ 0.2% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42195-550Ciprofloxacin OticCIPROFLOXACINXspire Pharma, LlcNDACurrent
42195-550Ciprofloxacin OticCIPROFLOXACINXspire PharmaNDACurrent
42195-550Ciprofloxacin OticCIPROFLOXACINXspire PharmaNDACurrent
66992-450CETRAXALCiprofloxacinWraser LlcNDACurrent
66992-450CETRAXALCiprofloxacinWraser LlcNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24228ORIG2009-10-06
21870ORIG2009-10-06
37873ORIG2009-05-11
28841ORIG2009-05-06
64788ORIG1900-01-01
53212ORIG1900-01-01
53211ORIG1900-01-01
53210ORIG1900-01-01