[Federal Register Volume 60, Number 120 (Thursday, June 22, 1995)]
[Rules and Regulations]
[Pages 32446-32447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for 46 new animal drug
applications (NADA's) from Sanofi Animal Health, Inc., to Rhone
Merieux, Inc.
EFFECTIVE DATE: June 22, 1995.
FOR FURTHER INFORMATION CONTACT: Judith M. O'Haro, Center for
Veterinary Medicine (HFV-238), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1737.
SUPPLEMENTARY INFORMATION: Sanofi Animal Health, Inc., 7101 College
Blvd., Overland Park, KS 66210, has informed FDA that it has
transferred ownership of, and all rights and interests in, the
following approved NADA's to Rhone Merieux, Inc., 7101 College Blvd.,
Overland Park, KS 66210:
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NADA number Drug name
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006-623............................ Caparsolate
008-422............................ Seleen Suspension
010-092............................ Gallimycin'-50P Premix
010-346............................ Combuthal Powder
012-123............................ Gallimycin-100, Gallimycin LA
Injectable, Erythro-200 Injection
033-157............................ Spectam Scour Halt
035-157............................ Gallimycin Poultry Formula
035-455............................ Gallimycin-36/Dry
035-456............................ Gallimycin 36 Sterile
038-241............................ Erythro +ZOA+ARS Acid
038-242............................ Erythro +AMP+ETHO
038-624............................ Pro-Gallimycin-10
038-661............................ Spectam Water Soluble Concentrate
040-040............................ Spectam Injection
041-955............................ Erythromycin Premix
044-756............................ Butatron Tablets
045-416............................ Butatron Injection
048-287............................ Oxytetracycline-50 Injection
055-002............................ Chloramphenicol Injection
055-059............................ Viceton Tablets
065-275............................ Penicillin VK Filmtab
065-276............................ Veesyn Granules for Oral Solution
065-383............................ Procaine G Penicillin Mastitis
Tubes
065-384............................ Procaine G Penicillin Mastitis
Tubes
093-483............................ Spectam Injectable
093-515............................ Spectam Tablets
095-218............................ Dexamethasone Tablets
097-397............................ Syncro-Mate-B
098-379............................ Cystorelin Injectable
100-128............................ Medipak Tylan 10
101-690............................ Erythro-100 Injectable
102-656............................ Gallimycin Poultry Formula
107-506............................ Carbam Tablets & Film Coated
Tablets
113-510............................ Equipalazone
118-032............................ Carbam Palatabs
118-979............................ Butatron Oral Gel
119-142............................ Injectable Iron 10%
120-615............................ Sustain III Calf & Cattle Bolus
123-815............................ Dexarnethasone Sodium Phosphate
Injection
124-241............................ Oxytocin Injection
126-504............................ Nitrozone Ointment
128-089............................ Dexamethasone Sterile Solution
134-930............................ Syncro-Mate-B
200-050............................ Neomycin 325 Soluble Powder
200-103............................ Penicillin G Potassium
200-147............................ Gentamicin Sulfate Injection
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Accordingly, FDA is amending the regulations in 21 CFR
510.600(c)(1) and (c)(2) to reflect the change of sponsor. The drug
labeler code assigned to Sanofi Animal Health, Inc., is being retained
as the drug labeler code for Rhone Merieux, Inc.
List of Subjects in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is
amended as follows:
PART 510--NEW ANIMAL DRUGS
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: Secs. 201, 301, 501, 502, 503, 512, 701, 721 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e). [[Page 32447]]
Sec. 510.600 [Amended]
2. Section 510.600 Names, addresses, and drug labeler codes of
sponsors of approved applications is amended in the table in paragraph
(c)(1) by removing the entry for ``Sanofi Animal Health, Inc.'' and by
alphabetically adding a new entry for ``Rhone Merieux, Inc., 7101
College Blvd., Overland Park, KS 66210......050604'' and in the table
in paragraph (c)(2) in the entry for ``050604'' by removing the sponsor
name ``Sanofi Animal Health, Inc.'' and adding in its place ``Rhone
Merieux, Inc., 7101 College Blvd., Overland Park, KS 66210''.
Dated: June 12, 1995.
George A. Mitchell,
Director, Office of Surveillance and Compliance, Center for Veterinary
Medicine.
[FR Doc. 95-15241 Filed 6-21-95; 8:45 am]
BILLING CODE 4160-01-F