21 CFR 522.1962 - Promazine hydrochloride.

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§ 522.1962 Promazine hydrochloride.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
(1) No. 000856 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.
(2) No. 061623 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section.
(c) Conditions of use—
(1) Horses—
(i) Amount— (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours.
(B) 0.2 to 0.5 mg/lb body weight intravenously as required.
(ii) Indications for use—
(A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus.
(B) For use as a tranquilizer and preanesthetic.
(iii) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Dogs and cats—
(i) Amount. 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours.
(ii) Indications for use. For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558