Title 21

SECTION 520.446

520.446 Clindamycin capsules and tablets.

§ 520.446 Clindamycin capsules and tablets.

(a) Specifications. (1) Each capsule contains the equivalent of 25, 75, 150, or 300 milligrams (mg) clindamycin as the hydrochloride salt.

(2) Each tablet contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(3) Each capsule contains the equivalent of 25, 75, or 150 mg clindamycin as the hydrochloride salt.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows:

(1) Nos. 054771 and 069043 for use of capsules described in paragraph (a)(1) of this section.

(2) No. 051311 for use of tablets described in paragraph (a)(2) of this section.

(3) No. 043806 for use of tablets described in paragraph (a)(3) of this section.

(c) Conditions of use in dogs - (1) Amount. Wounds, abscesses, and dental infections: 2.5 to 15 mg per pound (/lb) body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 mg/lb body weight every 12 hours for a minimum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.

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

[67 FR 54954, Aug. 27, 2002, as amended at 68 FR 55824, Sept. 29, 2003; 69 FR 32273, June 9, 2004; 71 FR 39204, July 12, 2006; 73 FR 4077, Jan. 24, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 28819, May 20, 2014; 80 FR 76386, Dec. 9, 2015; 81 FR 17607, Mar. 30, 2016]

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