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

Principal Display Panel – 20 mL Vial Label
(click image for full-size original)
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

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