CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.852]

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. 520.852 Estriol.

(a) Specifications. Each tablet contains 1 milligram (mg) estriol.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer at an initial dose of 2 mg per dog per day. The dosage may be titrated to as low as 0.5 mg per dog every second day, depending on response.

(2) Indications for use. For the control of estrogen-responsive urinary incontinence in ovariohysterectomized female dogs.

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

[76 FR 78150, Dec. 16, 2011]