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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 140-531 Tylan 5, 10, 20 & 40 Premix - original approval

Approval Date: July 26, 1986

I. GENERAL INFORMATION

NADA140-531
Sponsor:Agri-Basics
ConAgra-Westfeeds
1420 Minnesota Ave.
Billings, Montana 59101
Generic Name:tylosin (as tylosin phosphate)
Trade Name:Tylan 5, 10, 20 & 40 Premix
Marketing Status: 

 

II. INDICATIONS FOR USE

Swine: For increased rate of weight gain and improved feed efficiency. For prevention of swine dysentery (vibrionic). For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis. For treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water.

Beef Cattle: For reduction of incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes.

Chickens: For increased rate of weight gain and improved feed efficiency.

Laying Chickens: Improving feed efficiency.

Broiler and Replacement Chickens:

  • To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.
  • Feeds containing tylosin at 800 to 1000 grams per ton must be withdrawn five days before chickens are slaughtered.

 

III. DOSAGE FORM

Medicated Premix

The premix is to be added to the feed such that the complete feed contains:

  • Swine: 10 to 100 grams per ton of tylosin
  • Beef Cattle: 8 to 10 grams per ton of tylosin
  • Chickens: 14 to 50 grams per ton of tylosin
  • Broiler Chickens: 800 to 1000 grams per ton of tylosin
  • Replacement Chickens: 1000 grams per ton of tylosin
  • Laying Chickens: 20 to 50 grams per ton of tylosin

 

IV. SUMMARY OF SAFETY AND EFFECTIVENESS DATA

The safety and efficacy data upon which this application was approved are found in NADA 12-491 for Elanco Products Co. and are summarized in an FOI Summary in Docket Number 75N-0065.

 

V. AGENCY CONCLUSIONS

Approval of this application is based on safety and effectiveness data contained in Elanco Products Company's approved NADA 12-491. Use of the data in NADA 12-491 to support this application has been authorized by Elanco. This approval does not change the approved use of the drug. Consequently, approval of this NADA poses no increased human risk from exposure to residues of the animal drug, nor does it change the conditions of the drug's safe use in the target animal species. Accordingly, under the Center for Veterinary Medicine's supplemental approval policy (42 FR 64367), this is equivalent to a Category II supplemental approval which does no require reevaluation of the safety and effectiveness data in the original approval.

 

VI. LABELING

  1. Tylan 40 package label
  2. Tylan 20 package label

Copies of these labels may be obtained by writing to the:

Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855