FDA.reportPublic FDA data

Application 021537

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CIPRODEXCIPROFLOXACIN; DEXAMETHASONESUSPENSION/DROPS;OTIC0.3%;0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-8533CIPRODEXciprofloxacin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-8533CIPRODEXciprofloxacin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-8533CIPRODEXciprofloxacin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0065-8533CIPRODEXciprofloxacin and dexamethasoneAlcon Laboratories, Inc.NDACurrent
0078-0799CIPRODEXciprofloxacin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0799CIPRODEXciprofloxacin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0799CIPRODEXciprofloxacin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0799CIPRODEXciprofloxacin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0078-0799CIPRODEXciprofloxacin and dexamethasoneNovartis Pharmaceuticals CorporationNDACurrent
0781-6186Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6186Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6186Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasoneSandoz IncNDA AUTHORIZED GENERICCurrent
21695-969CIPRODEXciprofloxacin and dexamethasoneRebel Distributors CorpNDACurrent
63629-8797Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasoneBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8797Ciprofloxacin and Dexamethasoneciprofloxacin and dexamethasoneBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
68071-1629CIPRODEXciprofloxacin and dexamethasoneNuCare Pharmaceuticals,Inc.NDACurrent
71205-309CIPRODEXciprofloxacin and dexamethasoneProficient Rx LPNDACurrent
71205-309CIPRODEXciprofloxacin and dexamethasoneProficient Rx LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75355SUPPL 2023-09-05
65160SUPPL2020-11-06
65155SUPPL2020-11-04
57796SUPPL2019-02-22
57767SUPPL2019-02-22
15723SUPPL2015-12-15
28058SUPPL2015-12-14
21725SUPPL2015-08-25
42203ORIG2005-05-02
28057ORIG2003-07-28