Food and Drug Administration, HHS.
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.
Withdrawal of approval is effective May 21, 2001.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
The following sponsors have requested that FDA withdraw approval of the NADAs listed below because the products are no longer manufactured or marketed:
|Sponsor||NADA No. Product (Drug)||21 CFR Cite Affected (Sponsor Drug Labeler Code)|
|Purina Mills, Inc., P.O. Box 66812, St. Louis, MO 63166-6812||NADA 48-915 Purina® Bot Control (trichlorfon)||520.2520a (017800)|
|Golden Sun Feeds, Inc., 111 South Fifth St., Estherville, IA 51334||NADA 97-567 Tylan® 10 Premix (tylosin phosphate)||558.625(b)(17) (021780)|
|NADA 97-615 Swine Med-A-Mix TS 8000 Premix, Tylan® 5, 10, 20, 40 Sulfa-G (tylosin phosphate and sulfamethazine)||558.630(b)(4) and (b)(10) (021780)|
|Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska, MN 55318-1093||NADA 110-440 Hygromix Hygrowormer Hyanthelmix (hygromycin B)||558.274(a)(2), (a)(3), (a)(4), (c)(1)(i), and (c)(1)(ii) (016968)|
|Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 85043-4705||NADA 44-585 Oxytocin Injection||522.1680 (000402)|
|NADA 45-578 Lidocaine Hydrochloride with Epi-nephrine Injection 2%||522.1258 (000402)|
|NADA 45-737 Sodium Pentobarbital Injection||522.1704(b) (000402)|
|NADA 45-848 Phenylbutazone Injection||522.1720 (000402)|
|NADA 110-349 Dexamethasone Injection||522.540(c)(2) (000402)|
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|NADA 110-350 Dexamethasone Injection||522.540(b)(2)(ii) (000402)|
|NADA 117-973 Prednisolone Sodium Succinate for Injection||522.1884(c) (000402)|
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 § 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.Start Signature
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