Summary of 
FDA Information:
Date of 
Approval: December 18, 2001
FREEDOM OF INFORMATION SUMMARY
ANADA 200-293
Indication for 
use: It is used for 
the treatment of 
edema associated with cardiac
insufficiency, acute noninflammatory tissue edema, physiological parturient edema of 
the mammary gland and 
associated structures.
Sponsored by:
Phoenix Scientific, Inc.
St. Joseph, MO 64503.ANADA 200-293-E-0003 Page 2
FREEDOM OF INFORMATION SUMMARY
1. GENERAL INFORMATION:
ANADA Number 200-293
JINAD 10-179
Sponsor: Phoenix Scientific, Inc.
3915 S. 48 th St. Terrace
St. Joseph, MO 64503
21 CFR 510.600: Labeler Code 059130
Established Name: Furosemide Injection 5 %
Trade/Proprietary Name: Furosemide Injection 5 %
Dosage Form: Injectable
How Supplied: 50 & 100 mL multidose vials
How Dispensed: Rx
Amount of 
Active Ingredients: Each mL contains 50 mg of 
furosemide
as diethanolamine
Route of 
Administration: Intramuscularly or 
intravenously
Species: Cattle, horses, dogs and 
cats
Labeled Dosage Dog and 
cat-1/4 to ½ mL/10 lbs BID or 
SID
Horse-5 to 10 mL BID or 
SID
Cattle-5 mL BID or 
10 mL SID
Indications for 
Use: Diuretic-saluretic for 
prompt relief of 
edema
Pharmacological
Category: Diuretic-saluretic.ANADA 200-293-E-0003 Page 3
Pioneer Product: Lasix ® 5% Injection manufactured by
Intervet, Inc. (NADA 034-478)
2. TARGET ANIMAL SAFETY and 
DRUG EFFECTIVENESS
Under the provisions of 
the Federal Food, Drug, and 

Cosmetic Act, as amended by
the Generic Animal Drug and 
Patent Term Restoration Act, (53 FR 50460, December
15, 1988, First GADPTRA Policy Letter) an abbreviated 
new animal drug application
(ANADA) may be submitted for 
a generic version of 
an approved new animal drug
(pioneer product). New target animal safety data, drug effectiveness data, and 

human
food safety data (other than tissue residue data) are not required for 
approval of an
ANADA. An ANADA relies on the target animal safety, drug effectiveness, and 

human food safety data in the 
pioneer's new animal drug application.
The ANADA
sponsor is required to show that the 
generic product is bioequivalent to the pioneer.
ANADA’s for 
drug products for 
food-producing animals will generally be required to
include bioequivalence and 
tissue residue studies.
A tissue residue study 
will
generally be required to accompany clinical end-point and 
pharmacologic end-point
bioequivalence studies, and 

blood level bioequivalence studies that can not quantify
the concentration of 
the drug in blood throughout the established withdrawal period.
For certain dosage forms, the 
agency will grant a waiver from 
conducting an in vivo
bioequivalence study 
(55 FR 24645, June 18, 1990; Fifth GADPTRA Policy Letter;
Bioequivalence Guideline, October, 2000).
Based upon the formulation characteristics of 
the generic product, Phoenix Scientific,
Inc. was 
granted a waiver on September 29, 1997, from 
conducting an in vivo
bioequivalence study 
for Furosemide Injection 5 %.
The generic and 
pioneer
products contain the same active and 
inactive ingredients and 
are injectable solutions.
3. HUMAN FOOD SAFETY:
WITHDRAWAL TIME
When a waiver from 
the requirement of 
an in vivo bioequivalence study 
is granted, the 
withdrawal times are those previously assigned to the pioneer product.
The
withdrawal time for 
furosemide is established under 
21 CFR 522.1010- 48 hours in
cattle. Milk taken during treatment and 
for 
48 hours (four milkings) after the last
treatment must not be used for 
food.
Currently, there is no tolerance listed for 
the chemical component ‘furosemide’ in the 
Code of 
Federal Register( section 21 CFR 556).
HUMAN SAFETY RELATIVE TO POSSESSION, HANDLING, AND
ADMINISTRATION:
Labeling contains adequate caution/warning statements..ANADA 200-293-E-0003 Page 4
4. AGENCY CONCLUSIONS:
This Abbreviated New Animal Drug Application (ANADA) filed under 
section
512(b) of 
the Federal, Food, Drug and 
Cosmetic (FFD&C) Act satisfies the
requirements of 
section 512(n) of 
the Act and 
demonstrates that Furosemide Injection
5 % is safe and 
effective for 
its labeled indications, when 
used under 
its proposed
conditions of 
use.
5. LABELING:
Attachments: Pioneer Labeling:
Package Insert
50 mL vial
Generic Labeling:
Package Insert
50 mL & 100 mL vials
Copies of 
applicable labels may be obtained by writing to the:
Food and 
Drug Administration
Freedom of 
Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax,
call (301) 827-6567.