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

---
identifier: "/us/fr/01-11620"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Purina Mills, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications"
title_number: 0
title_name: "Federal Register"
section_number: "01-11620"
section_name: "Purina Mills, Inc., et al.; Withdrawal of Approval of New Animal Drug Applications"
positive_law: false
currency: "2001-05-09"
last_updated: "2001-05-09"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "01-11620"
document_type: "notice"
publication_date: "2001-05-09"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "66 FR 23717"
fr_volume: 66
docket_ids:
  - "Docket No. 01N-0179"
effective_date: "2001-05-21"
fr_action: "Notice."
---


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

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Notice.

**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:

| Sponsor | NADA No. Product | 21 CFR Cite Affected |
| --- | --- | --- |
| 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) |
|  | 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.

Dated: May 2, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.