[Federal Register Volume 66, Number 90 (Wednesday, May 9, 2001)]
[Notices]
[Pages 23717-23718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11620]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0179]


Purina Mills, Inc., et al.; Withdrawal of Approval of New Animal 
Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 11 new animal drug applications (NADAs) listed below. In a final 
rule published elsewhere in this issue of the Federal Register, FDA is 
amending the animal drug regulations to remove the portions reflecting 
approval of the NADAs because the products are no longer manufactured 
or marketed.

DATES: Withdrawal of approval is effective May 21, 2001.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION: The following sponsors have requested that 
FDA withdraw approval of the NADAs listed below because the products 
are no longer manufactured or marketed:

------------------------------------------------------------------------
                                                         21 CFR Cite
            Sponsor               NADA No. Product    Affected  (Sponsor
                                       (Drug)         Drug Labeler Code)
------------------------------------------------------------------------
Purina Mills, Inc., P.O. Box    NADA 48-915          520.2520a (017800)
 66812, St. Louis, MO 63166-     Purina
 6812.                           Bot Control
                                 (trichlorfon).
Golden Sun Feeds, Inc., 111     NADA 97-567          558.625(b)(17)
 South Fifth St., Estherville,   Tylan 10   (021780)
 IA 51334.                       Premix (tylosin
                                 phosphate).
 .............................  NADA 97-615 Swine    558.630(b)(4) and
                                 Med-A-Mix TS 8000    (b)(10) (021780)
                                 Premix,
                                 Tylan 5,
                                 10, 20, 40 Sulfa-G
                                 (tylosin phosphate
                                 and
                                 sulfamethazine).
Quali-Tech Products, Inc., 318  NADA 110-440         558.274(a)(2),
 Lake Hazeltine Dr., Chaska,     Hygromix             (a)(3), (a)(4),
 MN 55318-1093.                  Hygrowormer          (c)(1)(i), and
                                 Hyanthelmix          (c)(1)(ii)
                                 (hygromycin B).      (016968)
Steris Laboratories, Inc., 620  NADA 44-585          522.1680 (000402)
 North 51st Ave., Phoenix, AZ    Oxytocin Injection.
 85043-4705.
 .............................  NADA 45-578          522.1258 (000402)
                                 Lidocaine
                                 Hydrochloride with
                                 Epi-nephrine
                                 Injection 2%.
 .............................  NADA 45-737 Sodium   522.1704(b)
                                 Pentobarbital        (000402)
                                 Injection.
 .............................  NADA 45-848          522.1720 (000402)
                                 Phenylbutazone
                                 Injection.
 .............................  NADA 110-349         522.540(c)(2)
                                 Dexamethasone        (000402)
                                 Injection.

[[Page 23718]]

 
 .............................  NADA 110-350         522.540(b)(2)(ii)
                                 Dexamethasone        (000402)
                                 Injection.
 .............................  NADA 117-973         522.1884(c)
                                 Prednisolone         (000402)
                                 Sodium Succinate
                                 for Injection.
------------------------------------------------------------------------

    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10), redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADAs 44-585, 45-578, 45-737, 45-848, 48-915, 97-567, 97-
615, 110-349, 110-350, 110-440, and 117-973, and all supplements and 
amendments thereto, is hereby withdrawn, effective May 21, 2001.
    In a final rule published elsewhere in this issue of the Federal 
Register, FDA is amending the animal drug regulations to reflect the 
withdrawal of approval of these NADAs.

    Dated: May 2, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-11620 Filed 5-8-01; 8:45 am]
BILLING CODE 4160-01-S