MedPath
FDA Approval

Bystolic

January 3, 2012

HUMAN PRESCRIPTION DRUG LABEL

Nebivolol(5 mg in 1 1)

Manufacturing Establishments (1)

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

Products (2)

Bystolic

54868-5944

NDA021742

NDA (C73594)

ORAL

January 3, 2012

NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 5 mg in 1 1
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT

Bystolic

54868-6018

NDA021742

NDA (C73594)

ORAL

January 3, 2012

NebivololActive
Code: JGS34J7L9IClass: ACTIMQuantity: 10 mg in 1 1
cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8HClass: IACT
sodium lauryl sulfateInactive
Code: 368GB5141JClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6KClass: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
hypromellosesInactive
Code: 3NXW29V3WOClass: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5XClass: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT
starch, cornInactive
Code: O8232NY3SJClass: IACT
© Copyright 2025. All Rights Reserved by MedPath