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Veterinary Drugs

 
Product and
NADA/ANADA Number
Trade Name
Ingredients
Dichlorophene/toluene capsules
138-900
Dichlorophene/Toluene Capsules (Wormer for
Dogs and
Cats)
dichlorophene/toluene capsules

                                                                   
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Summary of 
FDA Information:

Approval Date: October 22, 1987 Freedom of
Information Summary NADA 138-900 I. GENERAL INFORMATION: NADA 138-900 Sponsor: Richlyn Laboratories, Inc. Philadelphia, PA 19124 Generic Name: Dichlorophene/Toluene Capsules Trade Name: Dichlorophene/Toluene Capsules (Wormer for
Dogs and
Cats) Marketing Status: OTC II. INDICATIONS FOR USE For removal of
ascarids (Toxocara canis and
Toxascaris leonina) and
hookworms (Ancylostoma caninum and
Uncinaria stenocephala) and
as an aid in removal of
tapeworms (Taenia pisiformis, Dipylidium caninum, and

Echinococcus granulosus) from
dogs and
cats. III. DOSAGE A. DOSAGE FORM Capsule B. ROUTE OF ADMINISTRATION Oral C. RECOMMENDED DOSAGES: The drug is administered orally at a dose of
100 mg of
dichlorophene and
120 mg of
toluene per pound of
body weight for
dogs and
cats. Solid foods and
milk should be withheld for
at least 12 hours prior to administration of
the drug and
for
4 hours afterwards. IV. EFFECTIVENESS This application is filed as a generic equivalent to Vermiplex Capsules. Vermiplex was
found to be effective by NAS/NRC review (NADA 6-691, Federal Register, February 1, 1969). Additionally, a regulation for
this preparation Dichlorophene/Toluene was
published as paragraph 520.580 for
reference claims. Jones, in Veterinary Pharmacology and
Therapeutics, 2nd Ed., cites in vitro studies which
support the safety and
effectiveness of
dichlorophene and
toluene worming products: Blair, H.E., "Vermiplex, a new anthelmintic for
dogs", North American Veterinarian, 30:306, 1949; and
Buren, G.R. and
Blair, H.E., "Vermiplex and
anthelmintic for
cats", North American Veterinarian,31:329, 1950.
These studies demonstrate that dichlorophene and
toluene are effective in removing certain ascarids and
hookworms, and

as an aid in removing certain tapeworms from
dogs and
cats. V. ANIMAL SAFETY Adequate data to establish the safety of
this drug in dogs and
cats are contained in the
application by R.P. Scherer Corporation Master File, MF 3464. No bioequivalency data are required because this product is produced by R.P. Scherer for
all sponsors. VI. HUMAN SAFETY A. Human Food Safety: Not applicable, for
use in dogs and
cats only. B. Human Safety relative to possession, handling, and

administration: Labeling contains adequate caution statement.
The product is packaged in child resistant closure (screwcaps). VII. AGENCY CONCLUSIONS Data submitted satisfy the requirements of
Section 512 of
the Act and
514.111 of
the implementing regulations.
The Center for
Veterinary Medicine concludes that this product is safe and
effective as labeled for
the above stated indications. VIII. LABELING (Attached) 1. Container labels for
1, 2.5, 5, 10, 25, 40 pound size dogs and
cats Copies of
these labels may be obtained by writing: Food and
Drug Administration Freedom of
Information Staff (HFI-35) 5600 Fishers Lane Rockville, MD 20857 Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.

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