YONSA- abiraterone acetate tablet

YONSA by

Drug Labeling and Warnings

YONSA by is a Prescription medication manufactured, distributed, or labeled by Catalent Pharma Solutions, LLC, Catalent Greenville, Inc., Sterling Chemical Malta Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Package/Label Display Panel Yonsa 125mg tablets

INGREDIENTS AND APPEARANCE

YONSA 
abiraterone acetate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 11014-0566
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ABIRATERONE ACETATE (UNII: EM5OCB9YJ6) (ABIRATERONE - UNII:G819A456D0)	ABIRATERONE ACETATE	125 mg

Product Characteristics
Color	white (to off-white)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	125;FP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11014-0566-1	12 in 1 BOX	10/03/2022	11/01/2025
1		120 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		10/03/2022	11/01/2025

Labeler - Catalent Pharma Solutions, LLC (825745131)

Registrant - Catalent Greenville, Inc. (118812386)

Establishment
Name	Address	ID/FEI	Business Operations
Catalent Greenville, Inc.		118812386	analysis(11014-0566) , pack(11014-0566) , manufacture(11014-0566)

Establishment
Name	Address	ID/FEI	Business Operations
Sterling Chemical Malta Ltd		360251875	api manufacture(11014-0566)