Animal & Veterinary
NADA 140-825 Swine Wormer-B - original approval
Approval Date: September 24, 1986
I. GENERAL INFORMATION:
120 E. Clark Street
Freeport, Illinois 61032
|Generic Name:||pyrantel tartrate|
|Trade Name:||Swine Wormer-B|
II. INDICATIONS FOR USE
- Continuous Feeding Program:
For aid in the prevention of migration and establishment of large round worm (Ascaris suum )infections; for aid in the prevention of establishment of nodular worm (Oesophagostomum ) infections of swine. Feed continuously as the sole ration.
- Three day Therapeutic Program:
For the removal and control of large roundworm (Ascaris suum ) infections of swine. Feed for three days as the sole ration.
- Single Therapeutic Program:
For the removal and control of large roundworm (Ascaris suum ) and nodular worm (Oesphagostomum ) infections of swine. Withdraw this feed 24 hours prior to slaughter.
III. DOSAGE FORM
Medicated Premix: The premixes are to be added to the feed such that the complete feed contains pyrantel tartrate equivalent to 96 grams (0.0106%) per ton of complete feed or 800 grams (0.0881%) per ton of complete feed.
IV. SUMMARY OF SAFETY AND EFFECTIVENESS DATA
The safety and efficacy data upon which this application was approved are found in NADA 43-290 for Pfizer, Inc., and are summarized in an FOI Summary in Docket Number 75N0217.
V. AGENCY CONCLUSION
Approval of this application relies on safety and effectiveness data contained in Pfizer's approved NADA 43-290. Use of the data in NADA 43-290 to support this application has been authorized by Pfizer. 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), the approval of this NADA has been treated as would an approval of a Category 2 change and did not require reevaluation of the safety and effectiveness data in NADA 43-290.
- 5 lb SWINE WORMER-B package label
- 10 lb SWINE WORMER-B 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