Federal Register - October 20, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations
57993
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2021Continued
lotter on DSK11XQN23PROD with RULES1
Approval date
File No.
Sponsor
Product name
Species
Effect of the action
Public documents
Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds.
Ractopamine hydrochloride, monensin, tylosin phosphate, and melengestrol acetate Type C medicated feeds.
KBROVETCA1 potassium bromide chewable tablets Chewable Tablet.
THYROKARE
levothyroxine sodium tablets.
Melengestrol acetate and monensin Type C
medicated feeds.
Cattle
Original approval as a generic copy of NADA 141234.
FOI Summary.
Cattle
Original approval as a generic copy of NADA 141233.
FOI Summary.
Dogs
Conditional approval for the control of seizures associated with idiopathic epilepsy in dogs.
FOI Summary.
Dogs
Original approval for replacement therapy for diminished thyroid function in dogs.
Original approval as a generic copy of NADA 125476.
FOI Summary.
Ractopamine hydrochloride, monensin, and melengestrol acetate Type C medicated feeds.
Melengestrol acetate, monensin, and tylosin phosphate Type C
medicated feeds.
Monensin, ractopamine hydrochloride, tylosin phosphate, and melengestrol acetate Type C medicated feeds.
SPARMECTIN Plus Clorsulon ivermectin and clorsulon Injection.
Cattle
Original approval as a generic copy of NADA 141234.
FOI Summary.
Cattle
Original approval as a generic copy of NADA 138870.
FOI Summary.
Cattle
Original approval as a generic copy of NADA 141233.
FOI Summary.
Cattle
Supplemental approval reducing preslaughter withdrawal period to 21
days.
FOI Summary.
ANIMEC PLUS
ivermectin and clorsulon Injection.
Cattle
Original approval as a generic copy of NADA 140833.
FOI Summary.
MACROSYN
tulathromycin injection Injectable Solution.
Cattle
Original approval as a generic copy of NADA 141244.
FOI Summary.
INCREXXA
tulathromycin injection Injectable Solution.
PENNITRACIN MD bacitracin Type A medicated article and COBAN monensin Type A medicated article to be used in the manufacture of Type C
medicated feeds.
Dexmedetomidine Hydrochloride Injection dexmedetomidine hydrochloride.
Cattle
Original approval as a generic copy of NADA 141244.
FOI Summary.
Turkeys
Original approval for the prevention of coccidiosis caused by Eimeria adenoeides, E. meleagrimitis and E.
gallopavonis, and for increased rate of weight gain and improved feed efficiency in growing turkeys.
FOI Summary.
Dogs and cats.
Original approval as a generic copy of NADA 141267.
FOI Summary.
January 12, 2021
200677
Do
January 12, 2021
200678
Do
January 14, 2021
141544
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL 32514.
January 15, 2021
141539
February 1, 2021
200683
February 1, 2021
200684
Neogen Corp., 944
Nandino Blvd., Lexington, KY 40511.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113
Sofia, Bulgaria.
Do
February 1, 2021
200685
Do
February 1, 2021
200686
Do
February 8, 2021
200466
February 16, 2021
200506
February 18, 2021
200657
February 18, 2021
200666
February 26, 2021
141540
Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS
66215.
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, County Galway, Ireland.
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
March 11, 2021
200699
VerDate Sep<11>2014
16:22 Oct 19, 2021
Akorn Animal Health, Inc., 1925 West Field Ct., Suite 300, Lake Forest, IL 60045.
Jkt 256001
PO 00000
Frm 00009
Fmt 4700
Sfmt 4700
Cattle
E:FRFM20OCR1.SGM
20OCR1
FOI Summary.
