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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1408]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1408 Methylprednisolone.

(a) Specifications. Each tablet contains 1, 2, or 4 milligrams (mg) of methylprednisolone.

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

(1) No. 069043 for use of 1- and 2-mg tablets.

(2) No. 054771 for use of 1- and 4-mg tablets.

(c) Conditions of use in dogs and cats - (1) Amount. 5 to 15 pounds (lbs): 2 mg; 15 to 40 lbs: 2 to 4 mg; 40 to 80 lbs: 4 to 8 mg. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed.

(2) Indications for use. As an anti-inflammatory agent.

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

[78 FR 28824, May 20, 2014, as amended at 83 FR 48946, Sept. 28, 2018]

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