FDA.reportPublic FDA data

Application 204251

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIMBRINZABRIMONIDINE TARTRATE; BRINZOLAMIDESUSPENSION/DROPS;OPHTHALMIC0.2%;1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0065-4147SIMBRINZAbrinzolamide/brimonidine tartrateAlcon Laboratories, Inc.NDACurrent
0078-0904SIMBRINZAbrinzolamide/brimonidine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0078-0904SIMBRINZAbrinzolamide/brimonidine tartrateNovartis Pharmaceuticals CorporationNDACurrent
0078-0904SIMBRINZAbrinzolamide/brimonidine tartrateNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74186SUPPL 2023-05-08
74185SUPPL 2023-05-08
19538SUPPL2015-11-12
32532SUPPL2015-11-09
24463ORIG2013-09-26
22948ORIG2013-09-26
32531ORIG2013-04-24
19537ORIG2013-04-23