Fluroxin For Dogs 2.27%: Product Information (Page 3 of 3)

Principal Display Panel – 20 mL Vial Label

NDC 46066-023-02

Pi vetal™

FLUROXIN™

(enrofloxacin)

INJECTION FOR DOGS 2.27%

For the Treatment of Susceptible Bacterial Pathogens in Dogs Only

CAUTION: Federal (U.S.A.) law restricts this drug
to use by or on the order of a licensed veterinarian.

Federal law prohibits the extralabel useof this drug in food-producing animals.

ANADA 200-513, Approved by FDA

50 mL

FLUROXIN FOR DOGS 2.27% enrofloxacin injection, solution

Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46066-023 Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength enrofloxacin (enrofloxacin) enrofloxacin 22.7 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46066-023-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS 1 20 mL in 1 VIAL, GLASS This package is contained within the CARTON (46066-023-01) 2 NDC:46066-023-02 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS 2 50 mL in 1 VIAL, GLASS This package is contained within the CARTON (46066-023-02) 3 NDC:46066-023-03 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS 3 100 mL in 1 VIAL, GLASS This package is contained within the CARTON (46066-023-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200513 08/01/2022

Labeler — Aspen Veterinary Resources (627265361)

Registrant — Norbrook Laboratories Limited (211218325)

Establishment
Name	Address	ID/FEI	Operations
Norbrook Laboratories Limited		211218325	ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 08/2022 Aspen Veterinary Resources