StacksVerified U.S. regulatory reference

21 CFR §522.2065

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine.
  2. (b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
  3. (c)Conditions of use in dogs—(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses.
    1. (2)Indications for use. For the treatment of lymphoma in dogs.
    2. (3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.