Federal Register - March 19, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 52 / Friday, March 19, 2021 / Rules and Regulations
TABLE 1ORIGINAL AND SUPPLEMENTAL NADAS AND ANADAS APPROVED DURING JULY, AUGUST, ANDContinued SEPTEMBER 2020
Approval date
File No.
September 29, 2020.
200528
Sponsor
Product name
Pharmgate, Inc, 1800 Sir Tyler Dr., Wilmington, NC 28405.
II. Changes of Sponsor Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140 has informed FDA
that it has transferred ownership of, and all rights and interest in, NADA 141
437 for OSNURIA betamethasone acetate, florfenicol, terbinafine Otic Gel to Dechra, Ltd., Snaygill Industrial
SAVALAN 60
salinomycin sodium Type A medicated article.
jbell on DSKJLSW7X2PROD with RULES
Original approval as a generic copy of NADA 011116.
FOI Summary.
Also, Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, KS 66201 has informed FDA
that it has transferred ownership of, and all rights and interest in, the 39 NADAs and 17 ANADAs listed below to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140:
Product name
VerDate Sep<11>2014
Chickens, quail
Public documents
Effect of the action
Estate, Keighley Rd., Skipton, North Yorkshire, BD23 2RW, United Kingdom.
Pharmasone LLC, 1800 Sir Tyler Dr., Wilmington, NC 28405 has informed FDA that it has transferred ownership of, and all rights and interest in, ANADA 200690 for ZOASHIELD 25%
zoalene Type A medicated article to Elanco US Inc., 2500 Innovation Way, Greenfield, IN 46140.
File No.
034641
040001
045416
047138
047955
047956
091818
093329
093483
107345
107346
111529
111607
111798
116089
132336
132337
132533
132789
133953
140441
140912
140913
141007
141008
141068
141099
141176
141208
141220
141247
141251
141254
141275
141344
141417
141435
141440
141527
200042
200124
200126
200137
200181
200202
200230
200246
200286
200293
200319
Species
TIGUVON fenthion Pour-On Cattle Insecticide.
MELDANE 2 coumaphos Type A Medicated Article.
TEVCODYNE phenylbutazone Injectable.
SPOTTON fenthion 20% Ready-to-Use Cattle Insecticide.
ROMPUN xylazine hydrochloride Injectable 20 mg.
ROMPUN xylazine hydrochloride Injectable 100 mg.
Phenylbutazone Tablets, USP 1 gram.
HAVASPAN sulfamethazine Prolonged Release Bolus; SULFASPAN sulfamethazine Prolonged Release Bolus.
SPECTAM spectinomycin hydrochloride Injectable Solution.
RINTAL febantel Paste.
RINTAL febantel Suspension.
EQUIMATE fluprostenol sodium.
DRONCIT praziquantel 5.68% Injectable Solution.
DRONCIT praziquantel Canine Cestocide Tablets; DRONCIT praziquantel Feline Cestocide Tablets.
VELTRIM clotrimazole 1% Dermatologic Cream.
PROBAN cythioate Oral Liquid.
PROBAN cythioate Tablets.
STYQUIN butamisole hydrochloride Parenteral 1.1%.
PROSPOT fenthion Solution.
VERCOM febantel and praziquantel Paste Anthelmintic.
BAYTRIL enrofloxacin Antibacterial Tablets; BAYTRIL TASTE TABS enrofloxacin Antibacterial Tablets.
RINTAL febantel Tabs Anthelmintic Tablets.
BAYTRIL enrofloxacin Antibacterial Injectable Solution.
DRONTAL Plus febantel, praziquantel, pyrantel pamoate Taste Tablets.
DRONTAL praziquantel and pyrantel pamoate Tablets.
BAYTRIL 100 enrofloxacin Injectable Solution.
CYDECTIN moxidectin Pour-On for Beef and Dairy Cattle.
BAYTRIL enrofloxacin and silver sulfadiazine Otic Emulsion.
ADVANTAGE DUO imidacloprid and ivermectin Topical Solution.
CYDECTIN moxidectin Injectable Solution.
CYDECTIN moxidectin Oral Drench for Sheep.
ADVANTAGE MULTI imidacloprid and moxidectin Topical Solution for Dogs.
ADVANTAGE MULTI imidacloprid and moxidectin Topical Solution for Cats.
PROFENDER emodepside and praziquantel Topical Solution.
VERAFLOX pradofloxacin Oral Suspension for Cats.
CORAXIS moxidectin Topical Solution.
ADVANTUS imidacloprid Tablets.
CLARO florfenicol, mometasone furoate, terbinafine Otic Solution.
BAYTRIL 100 enrofloxacin CA1.
Ketamine Hydrochloride Injection, USP.
Flunixin Meglumine Injection.
Phenylbutazone 20% Injection.
GENTAMAX 100 gentamicin sulfate Solution.
AMIMAX E amikacin sulfate Solution.
PHOENECTIN ivermectin Liquid for Horses.
Guaifenesin Injection.
ANTHELBAN V pyrantel pamoate Equine Anthelmintic Suspension.
PHOENECTIN ivermectin Paste 1.87%.
Furosemide Injection 5%.
Acepromazine Maleate Injection.
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