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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 140-820 Tylan 5, 10, 20 & 40 Sulfa-G Premixes - original approval

Approval Date: January 9, 1987

I. GENERAL INFORMATION:

NADA140-820
Sponsor:Furst-McNess Company
Freeport, Illinois 61032
Generic Name:tylosin (as tylosin phosphate) combined with sulfamethazine
Trade Name:Tylan 5, 10, 20 & 40 Sulfa-G Premixes
Marketing Status: 

 

II. Indications for Use:

For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebecterium pyogenes).

Feeds containing Tylosin and Sulfamethazine must be withdrawn 15 days before swine are slaughtered.

 

III. DOSAGE FORM

Medicated Premix: The premix is to be added to the feed such that the complete feed contains 100 grams of tylosin and 100 grams of sulfamethazine per ton.

 

IV. SUMMARY OF SAFETY AND EFFICACY

The safety and efficacy data upon which this application was approved are found in NADAs 12-491 and 41-275 for Elanco Products Company, and are summarized in an FOI Summary field with the Dockets Management Branch under the generic name of the drugs.

 

V. AGENCY CONCLUSION

Approval of this application is based on safety and effectiveness data contained in Elanco Products Company's approved NADAs 12-491 and 41-275. Use of the data in NADAs 12-491 and 41-275 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 application.

 

VI. LABELING

  1. Tylan 5 Sulfa-G 20 pound bag label
  2. Tylan 10 Sulfa-G 50 pound bag label
  3. Tylan 20 Sulfa-G 5 pound bag label
  4. Tylan 40 Sulfa-G 5 pound bag 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