FDA.reportPublic FDA data

Application 020816

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZOPTBRINZOLAMIDESUSPENSION/DROPS;OPHTHALMIC1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0275AzoptbrinzolamideAlcon Laboratories, Inc.NDACurrent
0065-0275AzoptbrinzolamideAlcon Laboratories, Inc.NDACurrent
0065-0275AzoptbrinzolamideAlcon Laboratories, Inc.NDACurrent
0065-0275AzoptbrinzolamideAlcon Laboratories, Inc.NDACurrent
0065-0275AzoptbrinzolamideAlcon Laboratories, Inc.NDACurrent
0078-0722AzoptbrinzolamideNovartis Pharmaceuticals CorporationNDACurrent
0078-0722AzoptbrinzolamideNovartis Pharmaceuticals CorporationNDACurrent
0781-6014BrinzolamideBrinzolamideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-6014BrinzolamideBrinzolamideSandoz IncNDA AUTHORIZED GENERICCurrent
63629-8793BrinzolamideBrinzolamideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8793BrinzolamideBrinzolamideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74685SUPPL 2023-07-03
74658SUPPL 2023-06-29
67906SUPPL2021-06-28
67889SUPPL2021-06-24
25892SUPPL2015-11-13
13472SUPPL2015-11-12
35400SUPPL2011-03-11
25891SUPPL2011-03-10
25890SUPPL2006-10-02
35399SUPPL2003-07-28
3408SUPPL2003-07-28
20974ORIG2003-06-19
35398ORIG1998-04-01
25889ORIG1998-04-01
51788ORIG1900-01-01
51787ORIG1900-01-01