FDA.reportPublic FDA data

Application 022212

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DUREZOLDIFLUPREDNATEEMULSION;OPHTHALMIC0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-9240DUREZOLDUREZOLAlcon Laboratories, Inc.NDACurrent
0065-9240DUREZOLDUREZOLAlcon Laboratories, Inc.NDACurrent
0065-9240DUREZOLDUREZOLAlcon Laboratories, Inc.NDACurrent
0065-9240DUREZOLDUREZOLAlcon Laboratories, Inc.NDACurrent
0065-9240DUREZOLDUREZOLAlcon Laboratories, Inc.NDACurrent
0078-0862DUREZOLdifluprednateNovartis Pharmaceuticals CorporationNDACurrent
0781-6000DUREZOLDifluprednate Ophthalmic EmulsionSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6000Difluprednate OphthalmicDifluprednate OphthalmicSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6000Difluprednate OphthalmicDifluprednate OphthalmicSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83964SUPPL 2025-10-28
83939SUPPL 2025-10-28
82892SUPPL 2025-07-25
82883SUPPL 2025-07-16
62853SUPPL2020-05-08
29414SUPPL2016-08-02
17096SUPPL2016-08-02
17095SUPPL2013-05-21
7060SUPPL2013-05-16
38391SUPPL2013-03-26
29413SUPPL2013-03-26
38390SUPPL2012-12-10
7059SUPPL2012-11-28
17094SUPPL2012-06-18
7058SUPPL2012-06-15
51515SUPPL2011-09-12
7057SUPPL2009-03-25
51514SUPPL2009-02-18
44704ORIG2008-07-25
21960ORIG2008-07-25
17093ORIG2008-06-24
7056ORIG2008-06-24
52613SUPPL1900-01-01
52612SUPPL1900-01-01
52611SUPPL1900-01-01