[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requested that the approval of the applications be withdrawn.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.

                                                                        
------------------------------------------------------------------------
                                                        Sponsor name and
            NADA No.                   Drug name            address     
------------------------------------------------------------------------
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  
------------------------------------------------------------------------

    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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