CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.1315]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1315 Maropitant.

(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs - (i) Amount. Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days.

(ii) Indications for use. For the prevention and treatment of acute vomiting.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats - (i) Amount. Administer 1.0 mg/kg of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days.

(ii) Indications for use. For the treatment of vomiting.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 9243, Mar. 1, 2007, as amended at 77 FR 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016]