FDA.reportPublic FDA data

Application 206911

Type
NDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BROMSITEBROMFENAC SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.075% ACIDYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49708-754BromSitebromfenacSun Pharmaceutical Industries, Inc.NDACurrent
49708-754BROMSITEbromfenacSun Pharmaceutical Industries, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73730SUPPL 2023-04-25
73724SUPPL 2023-03-10
52885ORIG2018-03-09
40573ORIG2016-04-13
32834ORIG2016-04-12