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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2011-N-0151]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 13 new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the 
                        **Federal Register**
                        , FDA is amending the regulations to remove portions reflecting approval of these NADAs.
 DATES: Withdrawal of approval is effective April 11, 2011.
 FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9079, e-mail: 
                        *john.bartkowiak@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION: The sponsors of the 13 approved NADAs listed in table 1 have requested that FDA withdraw approval because the products are no longer manufactured or marketed. Table 1—Voluntary Requests for Withdrawal of Approval of 13 NADAs
Sponsor
NADA No. Product (Established Name of Drug)
21 CFR Section Affected (Sponsor's Drug Labeler Code)Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ 07054-1298
NADA 093-029
                             UNITOP Cream 
                             (cuprimyxin)
524.520
                             (063238)Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318
NADA 097-981
                             TYLAN 40 Sulfa-G Premix 
                             (tylosin phosphate/sulfamethazine)
558.630
                             (016968)Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018
NADA 100-840
                             Chorionic Gonadotropin for Injection 
                             (chorionic gonadotropin)
522.1081
                             (063323)Furst-McNess Co., Freeport, IL 61032
NADA 100-991
                             McNess Custom Premix L200 
                             (tylosin phosphate)
558.625
                             (010439)Fort Dodge Animal Health, Division of Wyeth Holdings, a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York, NY 10017
NADA 101-079
                             TRAMISOL-10% Pig Wormer 
                             (levamisole)
Not codified
                             (000856)Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704
NADA 101-905
                             Mill Co-Medicator TY-10 
                             (tylosin phosphate)
558.625
                             (017139)Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704
NADA 101-906
                             Mill Co-Medicator TS-40 Premix 
                             (tylosin phosphate/sulfamethazine)
558.630
                             (017139)Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514
NADA 102-824
                             Phenylbutazone Tablets 
                             (phenylbutazone)
520.1720a
                             (055246)Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011
NADA 108-487
                             DEC Tabs 
                             (diethylcarbamazine citrate)
520.622a
                             (015579)Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN 56011
NADA 108-863
                             DEC Chewable Tabs 
                             (diethylcarbamazine citrate)
520.622c
                             (015579)Furst-McNess Co., Freeport, IL 61032
NADA 140-820
                             TYLAN 40 Sulfa-G Premix 
                             (tylosin phosphate/sulfamethazine)
558.630
                             (010439)Furst-McNess Co., Freeport, IL 61032
NADA 140-825
                             BANMINTH Intermediate Premix 
                             (pyrantel tartrate)
558.485
                             (010439)Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY 40511
NADA 140-910
                             NFZ Wound Powder 
                             (nitrofurazone)
524.1580c
                             (050749)
 Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 
                    *Notice of withdrawal of approval of application*
                     (21 CFR 514.116), notice is given that approval of NADAs 93-029, 97-981, 100-840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863, 140-820, 140-825, and 140-910, and all supplements and amendments thereto, is hereby withdrawn, effective April 11, 2011.
                    ( print page 17928) 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: March 25, 2011. Leslie Kux, Acting Assistant Commissioner for Policy.


[FR Doc. 2011-7558 Filed 3-30-11; 8:45 am] BILLING CODE 4160-01-P