Thursday, September 22, 2016

Robenz





Dosage Form: FOR ANIMAL USE
Robenz®

Robenidine Hydrochloride

Type A Medicated Article

Coccidiostat



Active drug ingredient


Robenidine hydrochloride 30 grams per pound (6.6%) in a carrier suitable for incorporation in feed.



For use in manufacturing medicated feeds only



Indications


Broiler chickens


As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix in broiler chickens only.



Use directions


Mix 1 pound of Robenz® Type A Medicated Article in one ton of feed to provide 30 grams per ton (0.0033%) robenidine hydrochloride concentration in feed.



Limitations


Feed continuously as the sole ration. Do not use in feeds containing bentonite.



Caution


Type C feeds containing Robenz robenidine hydrochloride must be fed within 50 days from the date of manufacture.



Warning


Do not feed to chickens producing eggs for food.

Withdraw 5 days prior to slaughter.



Note


Manufacture of Type B or C feeds from this product requires a Medicated Feed License Application approved by FDA.


Labels for feeds containing Robenz must contain appropriate indications, limitations and warnings as well as required feed ingredient information.



NADA 048-486, Approved by FDA



Marketed by

Alpharma Inc.

Bridgewater, New Jersey 08807


Net wt 50 LB (22.68 kg)



Trademarks registered by

Alpharma Inc.


Made in USA


740305 0905



PRINCIPAL DISPLAY PANEL - 50 LB Bag


Robenz®


ALPHARMA


Robenidine Hydrochloride

Type A Medicated Article

Coccidiostat


See back panel for use directions


Net wt 50 LB (22.68 kg)


ALPHARMA®


Robenz®










Robenz 
robenidine hydrochloride  powder










Product Information
Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGNDC Product Code (Source)46573-128
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Robenidine Hydrochloride (Robenidine)Robenidine30 g  in 0.45 kg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorBROWN (Buff to Tan)Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
146573-128-0022.68 kg In 1 BAGNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA04848601/01/2009


Labeler - Alpharma Inc. Animal Health (070954094)
Revised: 06/2009Alpharma Inc. Animal Health



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