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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 140-680 Tylan 5, 10, 20 & 40 Premix

Approval Date: July 24, 1987

I. GENERAL INFORMATION:

NADA140-680
Sponsor:Penfield Chemical Corporation
14040 Industrial Rd.
Omaha, Nebraska 68137
Generic Name:tylosin (as tylosin phosphate)
Trade Name:Tylan 5, 10, 20 & 40 Premix
Marketing Status: 

II. INDICATIONS FOR USE

  1. 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 the treatment and control of swine dysentery (vibrionic) following initial medication of Tylan Plus Vitamins in drinking water.
  2. Beef Cattle: For reduction in the incidence of liver abscesses caused by Sphaerophorus necrophorus and Corynebacterium pyogenes .
  3. Chickens: For increased rate of weight gain and improved feed efficiency.
  4. Laying Chickens: Improving feed efficiency.
  5. Broiler and Replacement Chickens: To aid in the control of chronic respiratory disease caused by Mycoplasma gallisepticum.

III. DOSAGE FORM

Medicated premix:

The premix is to be added to the feed such that the complete feed contains: (a) Swine: 10 to 100 grams per ton of tylosin; (b) Beef Cattle: 8 to 10 grams per ton of tylosin; (c) Chickens: 4 to 50 grams per ton of tylosin; (d) Broiler Chickens: 800 to 1000 grams per ton of tylosin; (e) Replacement Chickens: 1000 grams per ton of tylosin; (f) Laying Chickens: 20 to 50 grams per ton of tylosin.

Feeds containing Tylosin at 800 to 1000 grams per ton must be withdrawn 5 days before chickens are slaughtered.

IV. SUMMARY OF SAFETY AND EFFECTIVENESS

The safety and efficacy data upon which this application was approved are found in NADA 12-491 for Elanco Products Company, 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 not require reevaluation of the safety and effectiveness data in the original approval.

VI. LABELING

  1. Tylan® 40 product label

Copies of this label may be obtained by writing to the:

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