ARISTADA

Manufacturing Establishments (2)

Sharp Corporation

Labeler

Alkermes, Inc.

DUNS Number

143696495

Alkermes, Inc

Labeler

Alkermes, Inc.

DUNS Number

858582083

Products (4)

NDC Product Code

65757-404

Application Number

NDA207533

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR

Effective Date

January 15, 2021

Ingredients

Aripiprazole lauroxilActive

Code: B786J7A343Class: ACTIBQuantity: 1064 mg in 3.9 mL

Sorbitan MonolaurateInactive

Code: 6W9PS8B71JClass: IACT

Polysorbate 20Inactive

Code: 7T1F30V5YHClass: IACT

Sodium Phosphate, Dibasic, AnhydrousInactive

Code: 22ADO53M6FClass: IACT

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Sodium Phosphate, Monobasic, DihydrateInactive

Code: 5QWK665956Class: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

ARISTADA

NDC Product Code

65757-402

Application Number

NDA207533

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR

Effective Date

January 15, 2021

Ingredients

Aripiprazole lauroxilActive

Code: B786J7A343Class: ACTIBQuantity: 662 mg in 2.4 mL

Polysorbate 20Inactive

Code: 7T1F30V5YHClass: IACT

Sodium Phosphate, Dibasic, AnhydrousInactive

Code: 22ADO53M6FClass: IACT

Sorbitan MonolaurateInactive

Code: 6W9PS8B71JClass: IACT

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Sodium Phosphate, Monobasic, DihydrateInactive

Code: 5QWK665956Class: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

ARISTADA

NDC Product Code

65757-403

Application Number

NDA207533

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR

Effective Date

January 15, 2021

Ingredients

Aripiprazole lauroxilActive

Code: B786J7A343Class: ACTIBQuantity: 882 mg in 3.2 mL

Sorbitan MonolaurateInactive

Code: 6W9PS8B71JClass: IACT

Polysorbate 20Inactive

Code: 7T1F30V5YHClass: IACT

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Sodium Phosphate, Dibasic, AnhydrousInactive

Code: 22ADO53M6FClass: IACT

Sodium Phosphate, Monobasic, DihydrateInactive

Code: 5QWK665956Class: IACT

WaterInactive

Code: 059QF0KO0RClass: IACT

ARISTADA

NDC Product Code

65757-401

Application Number

NDA207533

Marketing Category

NDA (C73594)

Route of Administration

INTRAMUSCULAR

Effective Date

January 15, 2021

Ingredients

WaterInactive

Code: 059QF0KO0RClass: IACT

Sodium Phosphate, Monobasic, DihydrateInactive

Code: 5QWK665956Class: IACT

Aripiprazole lauroxilActive

Code: B786J7A343Class: ACTIBQuantity: 441 mg in 1.6 mL

Sorbitan MonolaurateInactive

Code: 6W9PS8B71JClass: IACT

Polysorbate 20Inactive

Code: 7T1F30V5YHClass: IACT

Sodium ChlorideInactive

Code: 451W47IQ8XClass: IACT

Sodium Phosphate, Dibasic, AnhydrousInactive

Code: 22ADO53M6FClass: IACT

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ARISTADA

Manufacturing Establishments (2)

Products (4)

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