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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 Mar 29, 2022.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR524.2080]



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 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.2080 Ropinirole.

(a) Specifications. Each milliliter of solution contains 30 milligrams (mg) ropinirole (equivalent to 34.2 mg ropinirole hydrochloride).

(b) Sponsor. See No. 052483 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount. Using the table provided in labeling, administer the number of eye drops topically, corresponding to body weight, that results in a target dose of 3.75 mg per square meter (mg/m 2) (dose band 2.7 to 5.4 mg/m 2). If the dog does not vomit within 20 minutes of the first dose, then a second dose may be administered.

(2) Indications for use. For the induction of vomiting in dogs.

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

[86 FR 13185, Mar. 8, 2021]

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