StacksVerified U.S. regulatory reference

21 CFR §522.1338

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
  2. (b)Sponsor. See No. 043264 in § 510.600(c) of this chapter.
  3. (c)Conditions of use—(1) Amount. Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m 2) BSA or use the dosing table provided in labeling.
    1. (2)Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.