FDA.reportPublic FDA data

Application 021742

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002BYSTOLICNEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 2.5MG BASEYesNo
003BYSTOLICNEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 5MG BASEYesNo
004BYSTOLICNEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 10MG BASEYesNo
005BYSTOLICNEBIVOLOL HYDROCHLORIDETABLET;ORALEQ 20MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1402Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1405Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1410Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
0456-1420Bystolicnebivolol hydrochlorideAllergan, Inc.NDACurrent
50090-1127Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-1127Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-1307Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-1307Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-1307Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-1307Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-3326Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-3326Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
50090-3326Bystolicnebivolol hydrochlorideA-S Medication SolutionsNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4621Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4622Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
55154-4623Bystolicnebivolol hydrochlorideCardinal HealthNDACurrent
68151-5135Bystolicnebivolol hydrochlorideCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74549SUPPL 2023-06-20
74543SUPPL 2023-06-20
50574SUPPL2017-12-01
50547SUPPL2017-12-01
28498SUPPL2011-12-15
16286SUPPL2011-12-14
16285SUPPL2010-03-03
6091SUPPL2010-02-26
42293ORIG2008-05-02
6090ORIG2008-01-09