Itrafungol: Product Information (Page 3 of 3)

Storage conditions

Store at 68-77°F (20-25°C). Excursions permitted between 59-86°F (15-30°C).

How supplied

ITRAFUNGOL is available in a glass bottle containing 52 mL of oral solution, closed with a child resistant screw cap and packaged in a cardboard box that includes a package insert and a graduated dosing syringe.

Approved by FDA under NADA # 141-474

Manufactured for Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161

Version Date: February 2022
xxxxxx — 01

© 2022 Virbac Corporation. All rights reserved.
ITRAFUNGOL is a registered trademark of Virbac S.A.

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ITRAFUNGOL
itraconazole injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-148
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
itraconazole (itraconazole) itraconazole 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-148-52 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 52 mL in 1 BOTTLE, GLASS This package is contained within the BOX (51311-148-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141474 05/04/2022
Labeler — Virbac AH, Inc (131568396)
Registrant — Virbac AH, Inc (131568396)

Revised: 05/2022 Virbac AH, Inc

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