FDA.reportPublic FDA data

Application 020805

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRO HCCIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONESUSPENSION/DROPS;OTICEQ 0.2% BASE;1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0065-8531CIPROciprofloxacin hydrochloride and hydrocortisoneAlcon Laboratories, Inc.NDACurrent
0078-0855CIPROciprofloxacin hydrochloride and hydrocortisoneNovartis Pharmaceuticals CorporationNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-1656CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
50090-6043CIPROciprofloxacin hydrochloride and hydrocortisoneA-S Medication SolutionsNDACurrent
76420-273CIPROciprofloxacin hydrochloride and hydrocortisoneAsclemed USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47686SUPPL2017-03-24
47625SUPPL2017-03-21
41714ORIG1998-02-10
13467ORIG1998-02-10
3397ORIG1998-02-10