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Title 21 → Chapter I → Subchapter E → Part 529 → §529.2620

Title 21: Food and Drugs
PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

§529.2620   Triptorelin.

(a) Specifications. Each milliliter of gel contains 100 micrograms (mcg) triptorelin as triptorelin acetate.

(b) Sponsor. See No. 051233 in §510.600(c) of this chapter.

(c) Conditions of use in swine—(1) Amount. Administer 200 mcg intravaginally approximately 96 hours after weaning.

(2) Indications for use. For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination.

(3) Limitations. Not approved for use in gilts. Safety and effectiveness have not been evaluated in these animals. Should not be used in sows with obvious reproductive tract abnormalities.

[77 FR 64717, Oct. 23, 2012]

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