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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
oxytetracycline
200-117
Oxyshot LA
oxytetracycline
200-232
Geomycin 200
Oxytetracycline
oxytetracycline + salinomycin sodium
140-448
Terramycin + Bio-Cox
oxytetracycline + salinomycin sodium
oxytetracycline amphoteric
113-232
Terramycin-10, 20, 50, 50D, 100, 100D, 100SS, & 200
oxytetracycline amphoteric
oxytetracycline dyhydrate pre-mix
095-143
OXTC 10, 30, 50, 50-S, 100, 100-S, 100MR
oxytetracycline dyhydrate pre-mix
oxytetracycline HCl
140-582
Oxytetracycline Hydrochloride Injection, 50 mg and
100 mg
oxytetracycline HCl
141-002
OXY 500 Claf Bolus / OXY 1000 Calf Bolus
Oxytetracycline HCL
200-066
AGRIMYCIN® 343 SOLUBLE POWDER
Oxytetracycline HCl
oxytetracycline hydrochloride
008-622
Terramycin®, Terramycin -343®
oxytetracycline hydrochloride
038-200
OXY WS (TM) Soluble Antibiotic; MEDAMYCIN ; Soluble Antibiotic
oxytetracycline hydrochloride
097-452
Oxyject; 100
oxytetracycline hydrochloride
130-435
OXYTET SOLUBLE
oxytetracycline hydrochloride
130-435
Oxytet Soluble, Tetravet-CA
Oxytetracycline hydrochloride
200-026
PennoxTM 343
Oxytetracycline hydrochloride
200-026
Pennox 343
oxytetracycline hydrochloride
200-066
AgrimynTM-343 Soluble Powder
oxytetracycline hydrochloride
200-068
OXYTETRACYCLINE Hydrochloride Injection
oxytetracycline hydrochloride
200-144
Undetermined
oxytetracycline hydrochloride
200-146
Oxytetracycline HCl Soluble Powder
oxytetracycline hydrochloride
200-247
Oxytetracycline HCL Soluble Powder-343
Oxytetracycline hydrochloride
Oxytetracycline Hydrochloride, USP
200-154
PennoxTM 200 Injection
Oxytetracycline Hydrochloride, USP
200-232
GEOMYCIN 200 Injection
Oxytetracycline Hydrochloride, USP
oxytetracycline injection
200-008
OXY-TETTM 200, BIO-MYCIN® 200
oxytetracycline injection
200-123
Maxim 200
oxytetracycline injection
200-154
Oxytetracycline 200
oxytetracycline injection
oxytetracycline pre-mix
138-938
Oxytetracycline 50, 100 & 100MR
oxytetracycline pre-mix
oxytetracycline Soluble Powder
008-622
Terramycin Soluble Powder
oxytetracycline Soluble Powder
Oxytetracycline Type A Medicated Article
008-804
TM-50®, TM-100®, TM-50®D, and

TM-100®D
Oxytetracycline Type A Medicated Article
095-143
OXTC®-50, OXTC®-100, and

OXTC®-200100MR
Oxytetracycline Type A Medicated Article

                                                                   
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Summary of 
FDA Information:

FREEDOM OF INFORMATION SUMMARY 1. General Information ANADA 200-117 Hybrid Application (refer to Agency Conclusions section at the
end of
the FOI Summary): This approval is based upon bioequivalence and
tissue residue studies, as required by Section 512(b)(2) and
additional target animal safety and
human food safety studies, as required by Section 512(b)(1) of
the Federal Food, Drug, and

Cosmetic Act. Generic Sponsor: Cross Vetpharm Group Limited Broomhill Road Tallaght, Dublin 24, Ireland a. Established Name: oxytetracycline injection b. Trade/Proprietary Name: Oxyshot™ LA c. Dosage Form: sterile injectable solution d. How Supplied: 100 mL, 250 mL, and

500 mL vials e. How Dispensed: OTC marketing status f. Amount of
Active Ingredient: 200 mg/mL g. Route of
Administration: Intramuscular in swine, intramuscular or
intravenous in cattle. h. Species: Beef Cattle, Non-lactating Dairy Cattle and
Swine i. Pharmacological Category Antimicrobial j. Indications for
Use: Oxyshot™ LA is intended for
use in the
treatment of
the following diseases in beef cattle, nonlactating dairy cattle and
swine when
due to oxytetracycline susceptible organisms. CATTLE Oxyshot™ LA is indicated in the
treatment of
pneumonia and
shipping fever complex associated with Pasteurella spp. and
Hemophilus spp.; infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis; foot rot and
diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus lignieresii; leptospirosis caused by Leptospira pomona; and
wound infections and
acute metritis caused by strains of
staphylococci and
streptococci organisms sensitive to oxytetracycline SWINE In swine, Oxyshot™ LA is indicated in the
treatment of
bacterial enteritis (scours, colibacillosis) caused by Escherichia coli; pneumonia caused by Pasteurella multocida; and
leptospirosis caused by Leptospira pomona. In sows, Oxyshot™ LA is indicated as an aid in the
control of
infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by Escherichia coli. k. Pioneer/NADA #: LIQUAMYCIN® LA-200; oxytetracycline injection; NADA #113-232; Pfizer l. Dosage CATTLE Oxyshot™ LA is to be administered by intramuscular or
intravenous injection to beef cattle and
nonlactating dairy cattle.
A single dose of
9 mg of
Oxyshot™ LA per pound of
body weight administered intramuscularly is recommended in the
treatment of
the following conditions: 1) bacterial pneumonia caused by Pasteurella spp. (shipping fever) in calves and
yearlings where retreatment is impractical. 2) infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis. Oxyshot™ LA can also be administered by intravenous or
intramuscular injection at a level of
3 to 5 mg of
oxytetracycline per pound of
body weight per day. In the treatment of
severe foot rot and
advanced cases of
other indicated diseases, a dosage level of
5 mg per pound of
body weight per day is recommended. Treatment should be continued 24 to 48 hours following remission of
disease signs; however, not to exceed a total of
four consecutive days. Consult your veterinarian if improvement is not noted within 24 to 48 hours of
the beginning of
treatment. SWINE A single dose of
9 mg of
Oxyshot™ LA per pound of
body weight administered intramuscularly is recommended in the
treatment of
bacterial pneumonia caused by Pasteurella multocida in swine, where retreatment is impractical. Oxyshot™ LA can be administered by intramuscular injection at a level of
3 to 5 mg of
oxytetracycline per pound of
body weight per day. Treatment should be continued 24 to 48 hours following remission of
diseases signs; however, not to exceed a total of
four consecutive days. Consult your veterinarian if improvement is not noted within 24 to 48 hours of
the beginning of
treatment. For sows, administer once intramuscularly 3 mg of
oxytetracycline per pound of
body weight approximately 8 hours before farrowing or
immediately after completion of
farrowing. For swine weighing 25 lb of
body weight and
under, Oxyshot™ LA should be administered undiluted for
treatment at 9 mg/lb but should be administered diluted for
treatment at 3 or
5 mg/lb. 3. TARGET ANIMAL SAFETY and
DRUG EFFECTIVENESS: The safety and
effectiveness of
Oxyshot™ LA was
established through the following bioequivalency and
target animal safety studies. BIOEQUIVALENCY STUDY WITH 200 MG/ML OXYTETRACYCLINE INJECTABLE IN CATTLE A. Type of
Study: Bioequivalency Study B. Investigator(s): Colorado Animal Research Enterprises, Inc. 6200 East County Road 56 Fort Collins, Colorado 80524 C. General Design of
the Investigation: 1. Purpose: To assess the in vivo bioequivalence of
Cross Vetpharm Group, Ltd. formulation of
oxytetracycline injection 200 mg/mL (Test Product) in cattle compared to Pfizer's 200 mg/mL Liquamycin® LA-200® (Reference Product) at the
recommended dosage of
9 milligrams per pound. 2. Test Animals: Crossbred, beef-type steer and
heifer calves, approximately 8-10 months of
age, weighing an average of
446 pounds were
randomly assigned to three groups. Groups I and
II contained 12 animals each and
Group III contained 2 animals as negative control animals for
a total of
twenty-six (26) test subjects.
The study
was conducted as a two-period crossover design in which
Group I received Test Product and
Group II received Reference Product in Period 1. Following a 42 day washout period, Group I received the Reference Product and
Group II received the Test Product as period 2. 3. Control Group: The two animals assigned to Group III were
designated as negative control animals.
These animals were
subject to the same handling as the test subjects (with the exception of
dosing procedures) to demonstrate a lack of
background oxytetracycline contamination in the
evaluation of
serum levels. 4. Diagnosis: Healthy test subjects were
used for
the purpose of
this study
. One day prior to each period, each calf received a veterinarian conducted physical examination encompassing assessment of
general appearance, respiratory and
GI tract auscultation, condition of
feces and
rectal temperature. 5. Dosage Form: The formulation of
Oxyshot™ LA to be marketed, a sterile injectable solution containing 200 mg/mL oxytetracycline base, was
used as the test article for
this study
. 6. Route of
Administration: Intramuscular injection. 7. Dosage(s): 9 milligrams oxytetracycline base per pound of
body weight. 8. Test Duration: November 5, 1991 through December 23, 1991. 9. Pertinent Parameters Measured: a. Health Examinations b. Clinical Evaluations c. Body Weights d. Serum Oxytetracycline Levels measured at appropriate intervals after treatment to determine Maximum Concentration (CMAX), Time to Maximum Concentration (TMAX), Elimination Rate (Ke), Elimination Half-Life (T1/2), Area Under the Curve (AUC), Area Under the Concentration x Time Curve (AUMC),and Mean Residence Time (MRT). D. Results: 1. Health Examinations - Abnormal findings in test subjects (during examination prior to drug administrations and
on observation during the blood collection and
washout periods) were
few and
of minor severity and
posed no interferences with study
objectives. 2. Clinical Evaluations - Blood hematology and
total serum protein analysis performed on blood specimens collected one day prior to the start of
period 2 indicated normal values for
all study
calves. Fecal samples were
collected one day prior to period 2 in response to a suspected coccidiosis outbreak in the
test subjects. Coccidia oocyst burdens were
found to be generally quite light among all study
animals. 3. Body Weights - The calves continued to gain weight during the washout period and
blood collections. 4. Serum Oxytetracycline Levels - Blood samples were
collected within ±1-3 minutes of
scheduled collection times. Serum was
harvested and
assayed for
oxytetracycline activity.
The individual serum levels were
tabulated and
the appropriate pharmacokinetic parameters calculated for
the test and
reference products. E. Statistical Analysis: Differences in the
pharmacokinetic parameters between Test and
Reference products were
statistically evaluated by means of
90% confidence intervals. Each endpoint of
the 90% confidence interval for
the difference in product means was
divided by the reference product mean. All such confidence intervals were
expressed as percentages by simply multiplying the endpoints by 100. Reference and
test product means for
each parameter are provided below, along with the corresponding confidence intervals. Variable Test Mean Reference Mean Lower Upper Area Under the Curve (AUC) 158.057 158.910 -3.919% 2.845% Area Under the Moment Curve(AUMC) 3893.12 4133.00 -9.793% -1.819% Maximum Concentration(CMAX) 5.0565 4.897 -1.616% 8.130% Time to Maximum Concentration (TMAX) 6.00 4.819 6.871% 42.134% Mean Residence Time (MRT) 24.565 25.974 -9.241% -1.604% F Conclusions: Based on a criterion that the
90% confidence interval for
the difference between product means be within ±20% of
the Reference Product mean, the
Test Product was
found to be bioequivalent to the Reference Product with respect to all pharmacokinetic parameters with the exception of
TMAX.
The Test Product took approximately 26% longer to reach Maximum concentrations; however, MRT, showed bioequivalence of
the 2 products. G. Adverse Reactions: No adverse reactions to the test or
reference product dosages were
noted during this study
. BIOEQUIVALENCY STUDY WITH Oxyshot™ LA (200 MG/ML OXYTETRACYCLINE INJECTABLE) IN SWINE A. Type of
Study: Bioequivalency Study B. Investigator(s): Colorado Animal Research Enterprises, Inc. 6200 East County Road 56 Fort Collins, Colorado 80524 C. General Design of
the Investigation: 1. Purpose: To assess the in vivo bioequivalence of
Cross Vetpharm Group, Ltd. formulation of
oxytetracycline injection 200 mg/mL Oxyshot™ LA in swine compared to Pfizer's 200 mg/mL Liquamycin® LA-200® (Reference Product) at the
recommended dosage of
9 milligrams per pound. 2. Test Animals: Crossbred, production-type barrows and
gilts (pigs), approximately 10-12 weeks of
age, weighing an average of
52 pounds were
randomly assigned to two groups. Each group contained 20 animals each.
The study
was conducted as a single-period parallel experimental design in which
Group I received Test Product and
Group II received Reference Product. 3. Control Group: No control group was
used in the
conduct of
this bioequivalency study
. 4. Diagnosis: Healthy test subjects were
used for
the purpose of
this study
. During acclimation, each pig received a general health examination as partial basis for
selection to the study
. Feed intake for
each pig was
also determined for
a 7 day period during acclimation to assist in assessing animal normalcy for
consideration as study
candidates. 5. Dosage Form: The formulation of
Oxyshot™ LA to be marketed, a sterile injectable solution containing 200 mg/mL oxytetracycline base, was
used as the test article for
this study
. 6. Route of
Administration: Intramuscular injection. 7. Dosage(s): 9 milligrams oxytetracycline base per pound of
body weight. 8. Test Duration: April 30, 1992 through May 4, 1992. 9. Pertinent Parameters Measured: a. Observations were
made twice daily to monitor the health status of
the pigs. b. Serum Oxytetracycline Levels measured at appropriate intervals after treatment to determine Maximum Concentration (CMAX), Time to Maximum Concentration (TMAX), Elimination Rate (Ke), Elimination Half-Life (T1/2_), Area Under the Curve (AUC), Area Under the Concentration x Time Curve (AUMC), Mean Residence Time (MRT), Area Under the Curve estimated to infinity (AUC), Area Under the Concentration x Time Curve estimated to infinity (AUMC),and Mean Residence Time estimated to infinity (MRT). D. Results: 1. Daily observations of
the pigs resulted in only minor and
incidental abnormalities. 2. Serum Oxytetracycline Levels - Blood samples were
collected within ±5 minutes of
scheduled collection times. Serum was
harvested and
assayed for
oxytetracycline activity.
The individual serum levels were
tabulated and
the appropriate pharmacokinetic parameters calculated for
the test and
reference products. E. Statistical Analysis: Differences in the
pharmacokinetic parameters between Test and
Reference products were
statistically evaluated by means of
90% confidence intervals. Each endpoint of
the 90% confidence interval for
the difference in product means was
divided by the reference product mean. All such confidence intervals were
expressed as percentages by simply multiplying the endpoints by 100. Reference and
test product means for
each parameter are provided below, along with the corresponding confidence intervals. Variable Test Mean Reference Mean Lower Upper Area Under the Curve (AUC) 80.986 75.864 -1.606% 15.108% Area Under the Moment Curve (AUMC) 1615.85 1523.58 -11.425% 23.538% Maximum Concentration (CMAX) 4.19 3.96 -3.275% 15.00% Time to Maximum Concentration (TMAX) 1.325 1.775 -71.256% 20.552% Mean Residence Time (MRT) 19.787 19.593 -10.685% 12.66%