[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34848-34849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16887]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0121]
Bayer Corp., et al.; Withdrawal of Approval of 29 NADA's
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 29 new animal drug applications (NADA's). Twenty-four NADA's are
held by Bayer Corp., Agriculture Division, Animal Health (formerly
Miles, Inc., Agriculture Division, Animal Health Products), three are
held by Hubbard Milling Co., and one each is held by Hoffmann-LaRoche,
Inc., and Ohmeda, Inc. The firms notified the agency in writing that
the animal drug products are not being manufactured or marketed and
requested that approval of the applications be withdrawn. In a final
rule published elsewhere in this issue of the Federal Register, FDA is
amending the animal drug regulations by removing the entries which
reflect approval of the NADA's.
EFFECTIVE DATE: July 15, 1996.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0159.
SUPPLEMENTARY INFORMATION: The sponsors of the applications listed in
the table in this document have informed FDA that these animal drug
products are not being manufactured or marketed and have requested that
FDA withdraw approval of the applications.
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Sponsor name and
NADA no. Drug name address
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6-462......................... Diethylcarbamazine Bayer Corp.,
tablets. Agriculture
Division, Animal
Health, P.O. Box
390, Shawnee
Mission, KS
66201.
10-540........................ Calcium disodium Do.
edetate injection.
11-380........................ Diethylcarbamazine Do.
powder.
12-054........................ Protokylol Do.
hydrochloride
tablets and
injection.
12-103........................ Triamcinolone Do.
tablets.
12-392........................ Triamcinolone Do.
injection.
12-598........................ Disophenol sodium Do.
injection.
15-161........................ Trichlorfon powder.. Do.
15-965........................ Coumaphos Type A Do.
medicated article.
30-045........................ Triamcinolone/ Do.
neomycin sulfate
ointment.
34-394........................ Niclosamide tablets. Do.
35-263........................ Styrylpyridinium Do.
chloride/
diethylcarbamazine
(as base) oral
liquid.
45-287........................ Coumaphos crumbles.. Do.
48-645........................ Tylosin Type A Hubbard Milling
medicated articles Co., 424 North
(5, 10, 20, and 40 Riverfront Dr.,
grams per pound). P.O. Box 8500,
Mankato, MN 56002-
8500.
49-555........................ Styrylpyridinium Bayer Corp.
chloride/
diethylcarbamazine
control diet HRH/
MSD.
91-628........................ Diethylcarbamazine Do.
citrate syrup.
93-372........................ Chlortetracycline Hoffmann-LaRoche,
calcium complex Inc., Nutley, NJ
Type A medicated 07110.
articles.
94-402........................ Tylosin and Hubbard Milling
sulfamethazine Type Co.
A medicated
articles.
95-078........................ Trichlorfon oral Bayer Corp.
liquid.
96-031........................ Styrylpyridinium Do.
chloride/
diethylcarbamazine
citrate tablets.
100-201....................... Trichlorfon paste... Do.
100-356....................... Styrylpyridinium Do.
chloride/
diethylcarbamazine
control diet HRH.
100-670....................... Niclosamide Type A Do.
medicated article.
101-078....................... Dichlorophene and Do.
toluene capsules.
120-327....................... Diethylcarbamazine Do.
chewable tablets.
120-670....................... Styrylpyridinium, Do.
diethylcarbamazine
edible tablets.
[[Page 34849]]
121-291....................... Enflurane liquid Ohmeda, Inc.,
(anesthetic). Pharmaceutical
Products
Division, P.O.
Box 804, Liberty
Corner, NJ 07938-
0804.
121-813....................... Styrylpyridinium, Bayer Corp.
diethylcarbamazine
film-coated tablets.
133-509....................... Pyrantel tartrate Hubbard Milling
Type A medicated Co.
articles.
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Therefore, under authority delegated to the Commissioner of Food
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal
of approval of applications (21 CFR 514.115), notice is given that
approval of NADA's 6-462, 10-540, 11-380, 12-054, 12-103, 12-392, 12-
598, 15-161, 15-965, 30-045, 34-394, 35-263, 45-287, 48-645, 49-555,
91-628, 93-372, 94-402, 95-078, 96-031, 100-201, 100-356, 100-670, 101-
078, 120-327, 120-670, 121-291, 121-813, and 133-509, and all
supplements and amendments thereto is hereby withdrawn, effective July
15, 1996.
In a final rule published elsewhere in this issue of the Federal
Register, FDA is removing 21 CFR 520.500, 520.620a, 520.620b, 520.1520,
520.2022, 520.2160a, 520.2160b, 520.2160c, 520.2160d, 520.2480,
520.2520c, 520.2520d, 522.281, 522.740, 522.2022, 522.2480, 529.810,
558.367, and 558.565, and amending 21 CFR 520.580, 520.622a, 520.622b,
520.2520a, 558.185, 558.485, 558.625, and 558.630 to reflect the
withdrawal of approval of the above mentioned NADA's.
Dated: June 3,1996.
Michael J. Blackwell,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 96-16887 Filed 7-2-96; 8:45 am]
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