Federal Register - March 8, 2021
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Source: Federal Register
13182
Federal Register / Vol. 86, No. 43 / Monday, March 8, 2021 / Rules and Regulations
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING APRIL, MAY, AND JUNE 2020
Continued Approval date
File No.
April 22, 2020
200673
April 27, 2020
200674
May 14, 2020
200679
May 21, 2020
200680
May 27, 2020
200638
May 28, 2020
200510
June 1, 2020
200134
June 2, 2020
200682
June 4, 2020
200399
June 15, 2020
141534
June 18, 2020
141535
Sponsor
Product name
jbell on DSKJLSW7X2PROD with RULES
Effect of the action
Public documents
Aurora Pharmaceutical, Inc., 1196 Highway 3
South, Northfield, MN
550573009.
Modern Veterinary Therapeutics, LLC, 14343 SW
119th Ave., Miami, FL
33186.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria.
Felix Pharmaceuticals Pvt.
Ltd., 2528 North Wall Quay, Dublin 1, Ireland.
Vetoquinol USA, Inc., 4250 N Sylvania Ave., Fort Worth, TX 76137.
Pharmgate, Inc., 1800 Sir Tyler Dr., Wilmington, NC 28405.
REVOLT selamectin Topical Solution.
Dogs and cats
Original approval as a generic copy of NADA 141152.
FOI Summary.
Detomidine Hydrochloride detomidine hydrochloride Injectable Solution.
OPTIGRID ractopamine HCl Type A Medicated Article.
Horses
Original approval as a generic copy of NADA 140862.
FOI Summary.
Cattle
Original approval as a generic copy of NADA 141221.
FOI Summary.
Enrofloxacin flavored tablets.
Dogs
Original approval as a generic copy of NADA 140441.
FOI Summary.
IMOXI Topical Solution for Cats imidacloprid and moxidectin.
Chlortetracycline Type B
and Type C medicated feeds.
Cats
Original approval as a generic copy of NADA 141254.
FOI Summary.
Cattle
N/A.
Intervet, Inc., 2 Giralda Farms, Madison, NJ
07940.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria.
Huvepharma EOOD, 5th Floor, 3A Nikolay Haytov Str., 1113 Sophia, Bulgaria.
Orion Corp., Orionintie 1, 02200 Espoo, Finland.
Zoetis Inc., 333 Portage St., Kalamazoo, MI
49007.
FERTAGYL gonadorelin Injectable Solution.
Cattle
Supplemental approval for use of DERACIN chlortetracycline Type A
medicated articles in the manufacture of Type B and Type C medicated feeds for control of bacterial pneumonia in beef cattle and replacement dairy heifers.
Supplemental approval for fixed-time artificial insemination in beef cows.
VETMULIN 12.5%
tiamulin hydrogen fumarate Liquid concentrate.
CYCLEGUARD
melengestrol acetate Type A liquid medicated article.
CLEVOR ropinirole ophthalmic solution.
Chlortetracycline, sulfamethazine, and lasalocid Type B and Type C medicated feeds.
Swine
Original approval as a generic copy of NADA 140916.
FOI Summary.
Cattle
Original approval as a generic copy of NADA 039402.
FOI Summary.
Dogs
Original approval for the induction of vomiting in dogs.
Original approval for use of AUREO S
700 chlortetracycline and sulfamethazine and BOVATEC
lasalocid in the manufacture of Type B and Type C medicated feeds for beef steers and heifers fed in confinement for slaughter.
FOI Summary.
II. Changes of Sponsor Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161 has informed FDA that it has transferred ownership of, and all rights and interest in, NADA
141084 for SENTINEL lufenuron and milbemycin oxime Flavor Tabs, NADA
141204 for the SENTINEL Flavor Tabs and CAPSTAR nitenpyram Flea Management System, and NADA 141
333 for SENTINEL SPECTRUM
lufenuron, milbemycin oxime, and praziquantel Chews to Intervet, Inc., 2
Giralda Farms, Madison, NJ 07940.
Also, Sparhawk Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS
66215 has informed FDA that it has transferred ownership of, and all rights and interest in, A 200348 for ECOMECTIN ivermectin Cattle PourOn to Huvepharma EOOD, 5th Floor, 3A
Nikolay Haytov Str., 1113 Sofia, Bulgaria. The animal drug regulations
VerDate Sep<11>2014
Species
16:10 Mar 05, 2021
Jkt 253001
Cattle
will be amended to reflect these changes of sponsor.
III. Technical Amendments FDA is making the following amendments to improve the accuracy and readability of the animal drug regulations:
The entries in 21 CFR 510.600c, 520.304, and 520.812 for Dechra Veterinary Products LLC are being amended to reflect the firms current drug labeler code.
The entries in 21 CFR 510.600c for Cronus Pharma Specialities India Private Ltd. are being amended to reflect the firms current address.
Conditions for use in 21 CFR
520.100 for use of amprolium crumbles in calves are being removed because no approved NADA exists for this dosage form product.
The regulations in part 526 21 CFR
part 526 for intramammary dosage form
PO 00000
Frm 00034
Fmt 4700
Sfmt 4700
FOI Summary.
FOI Summary.
drugs are being amended to reflect a current format and improve readability.
The section in part 529 21 CFR part 529 for sevofluorane anesthetic gas is being redesignated to reflect a current organizational scheme for dosage form new animal drugs.
Cross references in part 556 21 CFR
part 556 to related approved uses of new animal drugs are being amended as conforming changes to improve the accuracy of the regulations.
The table in 21 CFR 558.4 is being amended to reflect the correct format for displaying assay limits for component drugs in fixed-ratio, combination drug Type A medicated articles and Type B
and Type C medicated feeds.
Three tabular entries in 21 CFR
558.68 are being amended to reflect the approved conditions of use of certain feed use combinations, which had been removed in error.
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