Federal Register - October 20, 2021
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Source: Federal Register
57994
Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / Rules and Regulations
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JANUARY, FEBRUARY, AND MARCH
2021Continued Approval date
File No.
Sponsor
Species
Effect of the action
Public documents
Original approval for increased rate of weight gain, improved feed efficiency, and suppression of estrus heat in replacement dairy and beef heifers, or growing beef heifers fed in confinement for slaughter receiving medicated feed containing chlortetracycline for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, reduction of incidence of liver abscesses, and control of active infection of anaplasmosis.
Original approval for suppression of estrus heat in replacement dairy and beef heifers, or growing beef heifers fed in confinement for slaughter receiving medicated feed containing chlortetracycline for the treatment of bacterial enteritis or pneumonia, control of bacterial pneumonia associated with shipping fever complex, or control of active infection of anaplasmosis; and lasalocid for control of coccidiosis, increased rate of weight gain, and improved feed efficiency.
Original approval as a generic copy of NADA 140269.
FOI Summary.
March 15, 2021
141530
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
MGA melengestrol acetate Type A medicated article and AUREOMYCIN chlortetracycline Type A medicated article to be used in the manufacture of Type C medicated feeds.
Cattle
March 19, 2021
141531
Do
MGA melengestrol acetate Type A medicated article, AUREOMYCIN
chlortetracycline Type A medicated article, and BOVATEC
lasalocid Type A medicated article to be used in the manufacture of Type C medicated feeds.
Cattle
March 22, 2021
200625
KETOMED ketoprofen Sterile Solution.
Horses
March 24, 2021
132872
Bimeda Animal Health Ltd., 1B The Herbert Building, The Park, Carrickmines, Dublin 18, Ireland.
Intervet, Inc., 2 Giralda Farms, Madison, NJ
07940.
SAFEGUARD
fenbendazole Paste 10%.
Cattle
II. Changes of Sponsor
FDA that they have transferred ownership of, and all rights and interest
The sponsors of the following approved applications have informed File No.
Product name
141175
CAPSTAR nitenpyram Tablets
Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
141120
CLOMICALM clomipramine hydrochloride Tablets.
ITRAFUNGOL itraconazole oral solution.
GODRY penicillin G procaine Intramammary Infusion.
Do
Ampicillin Sodium Powder for Injection.
HANPEN penicillin G potassium Soluble Powder.
Chlortetracycline chlortetracycline hydrochloride Soluble Powder.
141474
065081
200335
200372
065071
lotter on DSK11XQN23PROD with RULES1
Product name
065440
200441
200528
VerDate Sep<11>2014
Jkt 256001
PO 00000
FOI Summary.
FOI Summary.
in, these applications to another sponsor:
Transferring sponsor
CHLORONEX chlortetracycline hydrochloride Soluble Powder.
A-MYCIN chlortetracycline hydrochloride Soluble Powder.
SAVALAN 60 salinomycin sodium Type A medicated article.
16:22 Oct 19, 2021
Supplemental approval providing for tolerances, a tissue withdrawal period, and a milk discard time in accordance with a repartitioning of the acceptable daily intake; and the addition of indications for fourth-stage larvae of certain endoparasites.
FOI Summary.
New sponsor
21 CFR
section
Sergeants Pet Care Products, Inc., 10077 S 134th St., Omaha, NE
68138.
Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161.
Do
520.1510.
526.1696.
Do
HQ Specialty Pharma Corp., 120
Rte. 17 North, Suite 130, Paramus, NJ 07652.
Do
Do
Do
520.1696a.
Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia, Bulgaria.
Do
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
520.441.
Do
Do.
Do
Do
Do.
Pharmgate Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia, Bulgaria.
558.550.
Do
G. C. Hanford Mfg. Co., P.O. Box 1017, Syracuse, NY 13201.
Frm 00010
Fmt 4700
Sfmt 4700
E:FRFM20OCR1.SGM
20OCR1
520.455.
520.1189.
522.90c.
