§520.1616. Orbifloxacin tablets.
21 C.F.R. § 520.1616
Specifications. Each tablet contains 5.7, 22.7, or 68 milligrams (mg) orbifloxacin.
Sponsor. See No. 000061 in § 510.600(c) of this chapter.
Conditions of use in dogs and cats—
Amount. 2.5 to 7.5 mg per kilogram body weight once daily.
Indications for use. For management of diseases associated with bacteria susceptible to orbifloxacin.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals.
Notes, amendments, and revision history
Amendments
[71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[71 FR 14643, Mar. 23, 2006, as amended at 75 FR 26646, May 12, 2010]