[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37651-37652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17924]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0173]
Procter & Gamble Pharmaceuticals, Inc., et al.; Withdrawal of
Approval of 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 16 new animal drug applications (NADA's). Fourteen NADA's are held
by Procter & Gamble Pharmaceuticals, Inc., and one each is held by
Lemmon Co. and Happy Jack, Inc. The firms notified the agency in
writing that the animal drug products were no longer marketed and
requested that the approval of the applications be withdrawn. In a
final rule published elsewhere in this issue of the Federal Register,
FDA is amending the regulations by removing the entries which reflect
approval of the NADA's.
EFFECTIVE DATE: July 31, 1995.
FOR FURTHER INFORMATION CONTACT: Mohammad I. Sharar, Center for
Veterinary Medicine (HFV-216), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1722.
SUPPLEMENTARY INFORMATION: The sponsors of the applications listed in
the table in this document have informed FDA that these animal drug
products are no longer 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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10-158......................... Furamazone, bismuth Procter & Gamble
subsalicylate bolus. Pharmaceuticals,
Inc., P.O. Box
191, Norwich, NY
13815
10-358......................... Nitrofurantoin do
tablets and boluses.
12-291......................... Nitrofurantoin oral do
suspension.
12-612......................... Nitrofurazone, do
nifuroxime,
diperodon
hydrochloride (HCl)
ear solution.
34-716......................... Buquinolate......... do
35-314......................... Buquinolate and do
bacitracin zinc.
35-315......................... Buquinolate, do
bacitracin zinc,
and penicillin.
35-317......................... Buquinolate and do
penicillin.
35-327......................... Buquinolate, do
bacitracin
methylene
disalicylate
(bacitracin MD),
and penicillin.
35-329......................... Buquinolate and do
bacitracin MD.
38-657......................... Buquinolate and do
chlortetracycline.
39-925......................... Buquinolate and do
roxarsone
combination.
39-926......................... Buquinolate and do
roxarsone.
41-744......................... Nitrofurantoin do
sodium injection.
95-017......................... Etorphine HCl Lemmon Co.,
injection and Sellersville, PA
diprenorphine HCl 18960
injection.
115-580........................ Piperazine adipate Happy Jack, Snow
powder. Hill, NC 28580
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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 10-158, 10-358, 12-291, 12-612, 34-716, 35-314, 35-
315, 35-317, 35-327, 35-329, 38-657, 39-925, 39-926, 41-744, 95-017,
115-580, and all supplements and amendments thereto is hereby
withdrawn, effective July 31, 1995..
In a final rule published elsewhere in this issue of the Federal
Register, FDA is removing 21 CFR 520.1560, 520.1560a, 520.1560b,
520.1801, 520.1801a, 522.1563, 524.1580a, 558.62(c)(2)(v), 558.105,
558.128(c)(5)(iii), 558.325(c)(3)(iv), 558.460(c)(2)(v), and
558.530(d)(3)(vii), and amending 21 CFR 510.600(c), 522.723, and
522.883 to reflect the withdrawal of approval of the above mentioned
NADA's.
[[Page 37652]]
Dated: July 13, 1995.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 95-17924 Filed 7-20-95; 8:45 am]
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