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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.304 - Carprofen.
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§ 520.304 Carprofen.
(a) Specifications.
(1) Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.
(2) Each chewable tablet contains 25, 75, or 100 mg carprofen.
(3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
(4) Each flavored tablet contains 25, 75, or 100 mg carprofen.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section.
(1) Nos. 017033, 054771, 055529, and 062250 , and 086101 for use of products described in paragraph paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section.
(2) Nos. 058198 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.
(3) No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.
(4) No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section.
(c) Conditions of use in dogs —
(1) Amount. 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.
(2) Indications for use. For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
(3) Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.
[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redesignated and amended at 80 FR 13229, Mar. 13, 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 88 FR 27698, May 3, 2023; 89 FR 42357, May 15, 2024]