ABILIFY MAINTENA - aripiprazole injection, powder, lyophilized, for suspension, extended release 
OTSUKA PHARMACEUTICAL CO., LTD.

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Abilify Maintena

((aripiprazole) for extended release injectable suspension)

300 mg Vials

Label of bulk for 300 mg vials

Image of 300-mg bulk label

Abilify Maintena

((aripiprazole) for extended release injectable suspension)

400 mg Vials

Label of bulk for 400 mg vials

Image of 400-mg bulk label

ABILIFY MAINTENA 
aripiprazole injection, powder, lyophilized, for suspension, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:46602-0023
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE300 mg  in 1.5 mL
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46602-0023-51.5 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20297109/01/201204/04/2013
ABILIFY MAINTENA 
aripiprazole injection, powder, lyophilized, for suspension, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:46602-0024
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARIPIPRAZOLE (ARIPIPRAZOLE) ARIPIPRAZOLE400 mg  in 2.0 mL
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:46602-0024-52.0 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20297109/01/201204/04/2013
Labeler - OTSUKA PHARMACEUTICAL CO., LTD. (690548318)

Revised: 04/2013
Document Id: 472c90ab-1e84-4f8b-8ce3-ea1f8f7db0af
Set id: e3e1c5e2-e038-4220-8900-0cf8935916f9
Version: 2
Effective Time: 20130405
 
OTSUKA PHARMACEUTICAL CO., LTD.