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Product and
Trade Name
halothane, USP
Halothane, USP
halothane, USP

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Summary of 
FDA Information:

FOI Summary; ANADA 200-200 (original); Halothane, USP (halothane, USP); April 10, 1997 --Editor's abstract Freedom of
Information Summary ANADA 200-200 1. GENERAL INFORMATION ANADA: 200-200 Sponsor: Halocarbon Products Corporation for
Halocarbon Laboratories P.O. Box661 887 Kinderkamack Road River Edge, NJ 07661 Trade Name: HALOTHANE, USP Accepted Name: Halothane, USP Dosage Form: Halothane, USP is a clear, colorless, stable liquid containing 0.01% Thymol as a pervative. How Supplied: HALOTHANE, USP is available in 250 mL amber-colored bottles. How Dispensed: Rx Amount of
Active Ingredients: Each mL contains 99.99% halothane Route of
Administration: Inhalation. Species: Dogs, cats, and

other non-food animals. Labeled Dosage(s): For induction of
anesthesia: The concentration of
Halothane, USP required to induce anesthesia will vary from
patient to patient but will usually be between 2% and
5%. Use of
an oxygen/nitrous oxide mixture will normally require a slightly lower concentration of
halothane to achieve the same plane of
anesthesia as opposed to use of
oxygen alone. Use of
a tranquilizer as a pre-anesthetic agent will also normally require a slightly lower concentration of
Halothane, USP. For maintenance of
anesthesia: The maintence dose of
Halothane, USP usually will vary between 0.5% to 2% in the
inhaled atmosphere. While under
the effects of
barbiturates the required maintenance concentration will normally be lower than after the effect of
the barbiturate has terminated Indications for
Use: HALOTHANE, USP (Halothane, USP) is used for
induction and
maintenance of
general anesthesia in dogs cats, and

other non-food animals. Pioneer Product: HALOTHANE, USP FORT DODGE LABORATORIES, Inc. Fort Dodge, Iowa 50501 NADA 14-170 2. TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS: Under the provisions of
the Federal Food, Drug, and

Cosmetic Act, as amended by the Generic Animal Drug and
Patent Term Restoration Act (53 FR 50460, December 15, 1988; first GADPTRA Policy Letter), an Abbreviated New Animal Drug Application (ANADA) may be submitted for
a generic version of
an approved new animal drug (pioneer product).
The sponsor of
the generic product must demonstrate that the
generic is bioequivalent to the pioneer. For certain dosage forms, the
Agency may grant a waiver from
conducting an in vivo bioequivalence study
(55 FR 24645, June 18, 1990; fifth GADPTRA Policy Letter). In lieu of
in vivo bioequivalence testing, the
bioequivalence of
the generic product is based on the demonstrated chemical equivalence. Based on the formulation characteristics of
the generic product, Halocarbon Products Corporation was
granted a waiver (see attached approval letter) from
conducting an in vivo bioequivalence study
with Halothane, USP.
The generic and
pioneer products are solutions with the same inactive ingredients and
the same concentrations of
the active ingredient. 3. HUMAN SAFETY: Human Safety Relative to Food Consumption: Regarding consumption of
drug residues in food, human safety data were
not required for
approval of this ANADA.
The drug is to be labeled for
use in dogs, cats and
other non-food animals. "Warning: Halothane, USP should not be used in animals for
use as food." Human Safety Relative to Possession, Handling and
Administration: A cautionary statement which
pertains to the safety of
this drug product for
humans is included in the
labeling of
the drug product, as follows: "Caution: Operating rooms should be provided with adequate ventilation to prevent the accumulation of
anesthetic vapors." 4. AGENCY CONCLUSIONS: This is an Abbreviated New Animal Drug Application (ANADA) filed under
Section 512(b)(2) of
the Federal, Food, Drug and
Cosmetic (FFD&C) Act. Bioequivalence of
this generic animal drug, Halothane, USP, to the pioneer product, FORT DODGE LABORATORIES HALOTHANE, USP (Halothane, USP, NADA 14-170). was
established by demonstration of
chemical equivalence.
This generic product and
the pioneer product have identical labeling indications for
The route and
method of
administration of
the two drugs are identical. Both drugs are administered by inhalation.
The generic and
pioneer products are both solutions that contain the same active and
inactive ingredients in the
same concentrations. Both products have the same pH.
Therefore, consistent with FDA policy implementing Section 512(b)(2) of
the FFD&C Act, no in vivo bioequivalency studies were
necessary or
This ANADA satisfies the requirements of
section 512 of
the Act and
demonstrates that (Halothane, USP), when
used under
its proposed conditions of
use, is safe and
effective for
its labeled indications. Attachments: Generic Labeling: Pioneer Labeling: 1. Package Insert 1. Package Insert 2. Label for
250 mL bottle 2. Label for
250 mL bottle Copies of
applicable labels may be obtained by writing to the: Freedom of
Information Office Center for
Veterinary Medicine, FDA 7500 Standish Place Rockville, MD 20855 --------------------------------------------------------------------------------

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