Food and Drug Administration, HHS.
Notification of withdrawal.
The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' request because these products are no longer manufactured or marketed.
Withdrawal of approval is effective March 25, 2019.
Sujaya Dessai, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5761,
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140, has requested that FDA withdraw approval of NADA 140–939 for use of RUMENSIN (monensin) and TYLAN (tylosin phosphate) Type A medicated articles in the manufacture of combination drug Type C medicated cattle feeds because the product is no longer manufactured or marketed.
Also, Sergeant's Pet Care Products, Inc., 10077 S 134th St., Omaha, NE 68138 has requested that FDA withdraw approval of ANADA 200–600 for WORMX (pyrantel pamoate) Flavored Tablets because the product is no longer manufactured or marketed.
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
Elsewhere in this issue of the