Summary of 
FDA Information:
FREEDOM OF INFORMATION SUMMARY

1. GENERAL INFORMATION

ANADA 200-108

ANADA Sponsor:

Phoenix Pharmaceutical, Inc.,
4621 Easton Road
P. O. Box 6457-Fairleigh Station
St. Joseph, Missouri 64506-0457

A. Established Name: dexamethasone solution

B. Trade Name: DEXAMETHASONE SOLUTION

C. Dosage Form: aqueous solution

D. How Supplied: 100 mL multiple dose vial 2 mg/mL

E. How Dispensed: Rx

F. Amount of 
Active Ingredients: 2 mg/mL

G. Route of 
Administration: IM or 
IV

H. Species: Bovine, Canine, Equine, Feline


I. Labeled Daily Dosage:  Bovine 5 to 20 mg 
    Canine 0.25 to 1 mg 
    Equine 2.5 to 5 mg 
    Feline 0.125 to 0.5 mg 



J. Indications for 
Use: Treatment of 
primary bovine ketosis and 
as an anti-inflammatory agent in dogs, cats cattle, and 

horses.

K. Pioneer Product: Azium® -DEXAMETHASONE SOLUTION 2 mg/mL by Schering Corp. under 
NADA 12-559.

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. Ordinarily, the 
ANADA sponsor shows that the 
generic product is bioequivalent to the pioneer. If bioequivalence is demonstrated through a clinical end-point study 
, then a tissue residue study 
to establish the withdrawal time for 
the generic product is also required. 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, April 1990).

Based upon the formulation characteristics of 
the generic product, Phoenix Pharmaceutical, Inc. was 
granted a waiver from 
conducting an in vivo bioequivalence study 
for DEXAMETHASONE SOLUTION.
The generic and 
pioneer products contain the same active and 
inactive ingredients and 
are administered as injectable solutions.

3. HUMAN FOOD SAFETY:

There is no withdrawal period associated with this or 
the pioneer product, therefore no human safety data pertaining to residues in food was 
required.
A 24 hour expiry is assigned to this generic product.

4. AGENCY CONCLUSIONS:

This ANADA submitted under 
section 512(b) of 
the Federal Food, Drug, and 

Cosmetic Act satisfies the requirements of 
section 512(n) of 
the act and 
demonstrates that DEXAMETHASONE SOLUTION when 
used under 
the proposed conditions of 
use, is safe and 
effective for 
its labeled indications.

Attachments: The following generic labeling and 
currently approved pioneer labeling are attached.

Generic labels: # 1. Phoenix regular and 
enlarged 100 mL vial label. 
   # 2. Phoenix package insert for 
vials (two pages) 
      
Pioneer labels # 3. Schering enlarged 100 mL vial label. 
   # 4. Schering package insert for 
vials.