[Federal Register Volume 59, Number 78 (Friday, April 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9700]


[[Page Unknown]]

[Federal Register: April 22, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0143]

 

Parke-Davis Pharmaceutical Research, et al.; Withdrawal of 
Approval of 31 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 31 abbreviated new drug applications (ANDA's). The holders of the 
ANDA's notified the agency in writing that the drug products were no 
longer marketed and requested that the approval of the applications be 
withdrawn
EFFECTIVE DATE: May 23, 1994.

FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug 
Evaluation and Research (HFD-360), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1038.

SUPPLEMENTARY INFORMATION: The holders of the ANDA's listed in the 
table in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications. The applicants have also, by their request, waived their 
opportunity for a hearing.

------------------------------------------------------------------------
ANDA no.                Drug                         Applicant          
------------------------------------------------------------------------
70-872     Nitroglycerin Injection, USP,   Parke-Davis Pharmaceutical   
            100 milligrams (mg) in 10       Research, 2800 Plymouth Rd.,
            milliliter (mL) Ampoules.       Ann Arbor, MI 48105.        
80-279     Prednisone Tablets, USP, 5 mg.  Inwood Laboratories, Inc.,   
                                            150 East 58th St., New York,
                                            NY 10155.                   
80-314     Chlorpromazine Hydrochloride    H. Reisman Corp., 337 Crane  
            Tablets, USP.                   St., Orange, NJ 07051.      
80-320     Prednisone Tablets, USP, 5 mg.  Heather Drug Co., Inc., c/o  
                                            Lachman Consultant Services,
                                            Inc., 1600 Stewart Ave.,    
                                            Westbury, NY 11590.         
80-328     Prednisone Tablets, USP, 1 mg.  Inwood Laboratories, Inc. 150
                                            East 58th St., New York, NY 
                                            10155.                      
80-748     Prednisolone Tablets, USP.....  Do.                          
80-784     Folic Acid Tablets, USP, 1 mg.  Purepac Pharmaceutical Co.,  
                                            200 Elmora Ave., Elizabeth, 
                                            NJ 07207.                   
80-839     Methyltestosterone Tablets, 10  Inwood Laboratories, Inc. 150
            mg.                             East 58th St., New York, NY 
                                            10155.                      
80-973     Methyltestosterone Tablets, 25  Do.                          
            mg.                                                         
83-270     Pentobarbital Sodium            Elkins-Sinn, Inc., 2         
            Injection, Inc..                Esterbrook Lane, Cherry     
                                            Hill, NJ 08003-4099.        
84-417     Prednisone Tablets, USP, 20 mg  Heather Drug Co., Inc. c/o   
                                            Lachman Consultant Services,
                                            Inc., 1600 Stewart Ave.,    
                                            Westbury, NY 11590.         
84-698     Hydrocortisone Gel, USP, 1%...  Galderma Laboratories, Inc., 
                                            3000 Alta Mesa Blvd., suite 
                                            300, P.O. Box 331329, Fort  
                                            Worth, TX 76163.            
84-776     Hydrochlorothiazide Tablets,    Inwood Laboratories, Inc. 150
            50 mg.                          East 58th St., New York, NY 
                                            10155.                      
85-507     Phendimetrazine Tartrate        Lemmon Co., 650 Cathill Rd., 
            Capsules, USP, 35 mg.           Sellersville, PA 18960.     
85-983     Theophylline Extended-Release   Whitby Pharmaceuticals Inc., 
            Capsules, USP, 260 mg.          2801 Reserve St., P.O. Box  
                                            27426, Richmond, VA 23261-  
                                            7426.                       
86-678     Cyproheptadine Hydrochloride    Mylan Pharmaceuticals Inc.,  
            Tablets, USP, 4 mg.             P.O. Box 4310, 781 Chestnut 
                                            Ridge Rd., Morgantown, WV   
                                            26505-4310.                 
87-196     Fluoxymesterone Tablets, USP,   ICN Pharmaceuticals, Inc.,   
            10 mg.                          ICN Plaza, 3300 Hyland Ave.,
                                            Costa Mesa, CA 92626.       
87-222     Methyltestosterone Tablets,     Do.                          
            USP, 5 mg.                                                  
87-679     Theophylline Elixir, 80 mg/15   Cenci Products, H.R. Cenci   
            mL.                             Laboratories, P.O. Box      
                                            12524, Fresno, CA 93778-    
                                            2524.                       
87-781     Methoxsalen Capsules, USP, 10   ICN Pharmaceuticals, Inc.,   
            mg.                             ICN Plaza, 3300 Hyland Ave.,
                                            Costa Mesa, CA 92626.       
87-854     Theophylline Extended-Release   Whitby Pharmaceuticals Inc., 
            Capsules, USP.                  2801 Reserve St., P.O. Box  
                                            27426, Richmond, VA 23261-  
                                            7426.                       
87-931     Lidocaine Hydrochloride USP,    The Kendall Co., Topical     
            4%.                             Solution, 15 Hampshire St., 
                                            Mansfield, MA 02048.        
87-961     Hydrocodone Bitartrate 5 mg     Forest Laboratories, Inc.,   
            Acetaminophen 500 mg Capsules.  150 East 58th St., New York,
                                            NY 10155-0181.              
87-980     Lidocaine Hydrochloride         Abbott Laboratories, One     
            Injection, USP, 10%.            Abbott Park Rd., Abbott     
                                            Park, IL 60064-3500.        
88-221     Fluoxymesterone Tablets 10 mg,  ICN Pharmaceuticals, Inc. ICN
                                            Plaza, 3300 Hyland Ave.,    
                                            Costa Mesa, CA 92626.       
88-283     Triprolidine Hydrochloride      Cenci Products H.R. Cenci    
            1.25 mg/5 mL and                Laboratories,. P.O. Box     
            Pseudoephedrine Hydrochloride   12524, Fresno, CA 93778-    
            30 mg/5 mL Syrup.               2424.                       
88-842     Hydrocortisone Ointment USP,    Pharmaderm, Baylis Rd.,      
            1%,.                            Melville, NY 11747.         
88-923     Hydrochlorothiazide USP, 50 mg  Lemmon Co., 650 Cathill Rd., 
            Tablets.                        Sellersville, PA 18960.     
88-924     Hydrochlorothiazide Tablets,    Do.                          
            USP, 25 mg.                                                 
89-019     Reserpine Tablets, USP, 0.25    Do.                          
            mg.                                                         
89-020     Reserpine Tablets, USP, 0.1 mg  Do.                          
------------------------------------------------------------------------

Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355(e)) and under authority delegated to the Director, 
Center for Drug Evaluation and Research (21 CFR 5.82), approval of the 
ANDA's listed above, and all amendments and supplements thereto, is 
hereby withdrawn, effective May 23, 1994.

    Dated: April 11, 1994.
 Murray M. Lumpkin,
 Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-9700 Filed 4-21-94; 8:45 am]
BILLING CODE 4160-01-F