FDA.reportPublic FDA data

Application 020369

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CILOXANCIPROFLOXACIN HYDROCHLORIDEOINTMENT;OPHTHALMICEQ 0.3% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0654CILOXANciprofloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0654CILOXANciprofloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0654CILOXANciprofloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0654CILOXANciprofloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0654CILOXANciprofloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0078-0841CILOXANciprofloxacin hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0841CILOXANciprofloxacin hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47269SUPPL2017-02-21
47268SUPPL2017-02-21
34564SUPPL2004-07-21
24856SUPPL2004-07-21
12494SUPPL2004-07-21
2402SUPPL2004-07-21
34563SUPPL2003-10-07
12493SUPPL2003-10-07
24855SUPPL2003-08-28
2401SUPPL2003-08-28
41303ORIG2003-05-15
12492ORIG1998-03-30
2400ORIG1998-03-30