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    Synovex Component E-H

    Posted by: WheelBarrel

    Synovex Component E-H is the same as Synovex-H

    Synovex Component E-H
    Each CARTRIDGE BELT holds 20 doses of COMPONENT® E-H Implants.
    Each dose of 8 pellets contains a total of 200 mg testosterone propionate USP and 20 mg estradiol benzoate.


    SYNOVEX® H
    Fort Dodge

    HEIFER IMPLANTS

    For Increased Rate of Weight Gain and Improved Feed Efficiency

    NADA 11-427, Approved by FDA

    Each dosage consists of 8 pellets containing 200 mg testosterone propionate and 20 mg estradiol benzoate
    This product was manufactured by a non-sterilizing process.

    Synovex H Heifer Implants contain two pure steroid hormones, testosterone propionate and estradiol benzoate. This formulation provides a complementary amount of each hormone for maximal growth stimulation. Study the enclosed instructions carefully and use this product only as illustrated.

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    Code of Federal Regulations
    DEPARTMENT OF JUSTICE
    Drug Enforcement Administration
    21 CFR Part 1308
    [DEA No. 161F]


    Schedules of Controlled Substances: Excluded Veterinary Anabolic steroid Implant Products

    AGENCY: Drug Enforcement Administration, Department of Justice

    ACTION: Final rule.

    SUMMARY: The interim rule (62 FR 29289, May 30, 1997) which identified eight veterinary anabolic steroid implant products as being exempt from the Controlled Substances Act (CSA) (21 U.S.C. 801 et seq.) is adopted without change.

    DATES: Effective Date: October 3, 1997.

    FOR FURTHER INFORMATION CONTACT: Frank L. Sapienza, Chief, Drug and Chemical Evaluation Section, 202-307-7183

    SUPPLEMENTARY INFORMATION: The Acting Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration (DEA), published in the Federal Register, an interim rule which identified eight products as being excluded veterinary anabolic steroid implant products (62 FR 29289, May 30, 1997). Comments were requested, none were received.

    Therefore, pursuant to the authority delegated to the Administrator of the DEA pursuant to 21 U.S.C. 871(a) and 28 CFR 0.100 and redelegated to the Deputy Assistant Administrator of the Drug Enforcement Administration Office of Diversion Control, pursuant to 28 CFR 0.104, appendix to subpart R, section 7(g)9, the Deputy Assistant Administrator of the Office of Diversion Control, hereby adopts as a final rule, without change, the interim rule amending 21 CFR 1308.26 which was published at 62 FR 29289 on May 30, 1997.

    The veterinary anabolic steroid implant products which are described in 21 CFR 1308.26 are excluded from application of the CSA in relation to their production, distribution, and use in animals only. If any person distributes, dispenses or otherwise diverts these products to use in humans, he/she shall be deemed to have distributed a Schedule III controlled substance and may be prosecuted for CSA violations. The veterinary anabolic steroid implants products which are excluded from application of the CSA are as follows:
    EXCLUDED VETERINARY ANABOLIC steroid IMPLANT PRODUCTS

    Trade name Component E-H
    Company VetLife, Inc., Norcross GA
    NDC or DIN No. 021641-002
    Delivery System 20 implant belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Component E-H
    Company Elanco, Scarborough, ON
    NDC or DIN No. 01968327
    Delivery System 20 implant belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Component TE-S
    Company VetLife, Inc., Norcross, GA
    NDC or DIN No. 021641-004
    Delivery System 20 implant belt, 6 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 120 mg/implant (20 mg/pellet)
    Estradiol 24 mg/implant (4 mg/pellet)
    Trade name Component T-H
    Company VetLife, Inc., Norcross, GA
    NDC or DIN No. 021641-006
    Delivery System 20 implant belt, 10 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 200 mg/implant (20 mg/pellet)
    Trade name Component T-S
    Company VetLife, Inc., Norcross, GA
    NDC or DIN No. 021641-005
    Delivery System 0 implant belt, 7 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 140 mg/implant (20 mg/pellet)
    Trade name F-TO
    Company Animal Health, Upjohn International, Kalamazoo, MI
    NDC or DIN No. 00093351
    Delivery System 20 implant cartridge belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Oestradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Finaplix-H
    Company Hoechst Roussel Vet, Somerville, NJ
    NDC or DIN No. 12799-807-10
    Delivery System 10 implant cartridge, 10 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 200 mg/implant (20 mg/pellet)
    Trade name Finaplix-S
    Company Hoechst Roussel Vet, Somerville, NJ
    NDC or DIN No. 12799-807-07
    Delivery System 10 implant cartridge, 7 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 140 mg/implant (20 mg/pellet)
    Trade name Heifer-oid
    Company Anchor Division, Boehringer Ingelheim, St. Joseph, MO
    NDC or DIN No.
    Delivery System Single & 20 implant cartridge belts, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Heifer-oid
    Company Bio-Ceutic Division, Boehringer Ingelheim, St. Joseph, MO
    NDC or DIN No.
    Delivery System 20 implant cartridge belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Heifer-oid
    Company Ivy Laboratories, Inc., Overland Park, KS
    NDC or DIN No.
    Delivery System Single & 20 implant cartridge belts, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Implus-H
    Company The Upjohn Co., Kalamazoo, MI
    NDC or DIN No. 0009-0434-01
    Delivery System 20 implant cartridge belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Implus-H
    Company Upjohn Co., Animal Health Div., Orangeville, ON
    NDC or DIN No. 06-0434-01 01968327
    Delivery System 20 implant cartridge belt, 8 pellets/implant

    Ingredients Quantity
    Testosterone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Revalor-G
    Company Hoechst Roussel Vet, Somerville, NJ
    NDC or DIN No. 12799-811
    Delivery System 10 implant cartridge, 2 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 40 mg/implant (20 mg/pellet)
    Estradiol 4 mg/implant (2 mg/pellet)
    Trade name Revalor-H
    Company Hoechst Roussel Vet, Somerville, NJ
    NDC or DIN No. 12799-810
    Delivery System 10 implant cartridge, 7 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 140 mg/implant (20 mg/pellet)
    Estradiol 14 mg/implant (2 mg/pellet)
    Trade name Revalor-S
    Company Hoechst Roussel Vet, Somerville, NJ
    NDC or DIN No. 12799-809
    Delivery System 10 implant cartridge, 6 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 120 mg/implant (20 mg/pellet)
    Estradiol 24 mg/implant (4 mg/pellet)
    Trade name Synovex H
    Company Fort Dodge Labs, Fort Dodge, IA
    NDC or DIN No. 0856-3901
    Delivery System 10 implant cartridge, 8 pellets/implant

    Ingredients Quantity
    Trenbolone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Synovex H
    Company Syntex Laboratories, Palo Alto, CA
    NDC or DIN No.
    Delivery System 10 implant cartridge, 8 pellets/implant

    Ingredients Quantity
    Trenbolone propionate 200 mg/implant (25 mg/pellet)
    Estradiol benzoate 20 mg/implant (2.5 mg/pellet)
    Trade name Synovex Plus
    Company Fort Dodge Labs, Fort Dodge, IA
    NDC or DIN No. 0856-3904
    Delivery System 10 implant cartridge, 8 pellets/implant

    Ingredients Quantity
    Trenbolone acetate 200 mg/implant (25 mg/pellet)
    Estradiol 28 mg/implant (3.5 mg/pellet)

    In accordance with the provisions of 21 U.S.C. 811(a) of the CSA, this action is a formal rulemaking "on the record after opportunity for a hearing." Such proceedings are conducted pursuant to the provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review by the Office of Management and Budget pursuant to Executive Order (E.O.) 12866, section 3(d)(1).

    The Deputy Assistant Administrator, Office of Diversion Control, in accordance with the Regulatory Flexibility Act [5 U.S.C. 605(b)], has reviewed this rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small-business entities. The inclusion of a product in 21 CFR 1308.26 relieves persons who handle the product in the course of legitimate business from the requirements imposed by the CSA.

    This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under provisions of the Unfunded Mandates Reform Act of 1995.

    This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign-based companies in domestic and export markets.

    This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with E.O. 12612, it is determined that this rule will not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.


    Dated: September 8, 1997

    John H. King,

    Deputy Assistant Administrator,
    Office of Diversion Control,
    Drug Enforcement Administration

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