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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR529.2620]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 529 -- CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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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