[Federal Register Volume 66, Number 151 (Monday, August 6, 2001)]
[Notices]
[Pages 41029-41031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0317]


Mylan Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 66 
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 66 abbreviated new drug applications (ANDAs). The holders of the 
applications notified the agency in

[[Page 41030]]

writing that the drug products were no longer marketed and requested 
that the approval of the applications be withdrawn.

DATES: Effective September 5, 2001.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: The holders of the applications 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
------------------------------------------------------------------------
61-755......................  Ampicillin Capsules   Mylan
                               USP, 250 milligrams   Pharmaceuticals,
                               (mg) and 500 mg..     Inc., 781 Chestnut
                                                     Ridge Rd., P.O. Box
                                                     4310, Morgantown,
                                                     WV 26504.
62-090......................  Amoxicillin for Oral  Do.
                               Suspension USP, 125
                               mg/5 milliliters
                               (mL) and 250 mg/5
                               mL..
62-928......................  Clindamycin           AstraZeneca, 725
                               Phosphate Injection   Chesterbrook Blvd.,
                               USP, 150 mg/mL..      Wayne, PA 19087-
                                                     5677.
63-167......................  Amikacin Sulfate      Do.
                               Injection USP, 50
                               mg (base)/mL..
63-169......................  Amikacin Sulfate      Do.
                               Injection USP, 250
                               mg (base)/mL..
70-095......................  Furosemide Injection  Do.
                               USP, 10 mg/mL..
70-096......................  Furosemide Injection  Do.
                               USP, 10 mg/mL..
70-529......................  Indomethacin          Watson Laboratories,
                               Capsules USP, 25      Inc., 311 Bonnie
                               mg..                  Circle, Corona, CA
                                                     92880.
70-530......................  Indomethacin          Do.
                               Capsules USP, 50
                               mg..
70-645......................  Metoclopramide        Do.
                               Tablets, 10 mg..
71-920......................  Methyldopa and        Do.
                               Hydrochlorothiazide
                               Tablets USP, 250 mg/
                               15 mg..
71-921......................  Methyldopa and        Do.
                               Hydrochlorothiazide
                               Tablets USP, 250 mg/
                               25 mg..
71-922......................  Methyldopa and        Do.
                               Hydrochlorothiazide
                               Tablets USP,500 mg/
                               30 mg..
71-923......................  Methyldopa and        Do.
                               Hydrochlorothiazide
                               Tablets USP, 500 mg/
                               50 mg..
72-023......................  Metaproterenol        Muro
                               Sulfate Syrup USP,    Pharmaceuticals,
                               10 mg/5 mL..          Inc., 890 East St.,
                                                     Tewksbury, MA
                                                     01876.
72-081......................  Naloxone              AstraZeneca.
                               Hydrochloride (HCl)
                               Injection USP, 0.02
                               mg/mL..
72-086......................  Naloxone HCl          Do.
                               Injection USP, 0.4
                               mg/mL..
72-091......................  Naloxone HCl          Do.
                               Injection USP, 1 mg/
                               mL..
72-165......................  Fenoprofen Tablets    Watson Laboratories,
                               USP, 600 mg..         Inc.
72-293......................  Fenoprofen Capsules   Do.
                               USP, 300 mg..
72-294......................  Fenoprofen Capsules   Do.
                               USP, 200 mg..
72-372......................  Duphalac (Lactulose   Solvay
                               Solution USP), 10     Pharmaceuticals,
                               grams/15 mL..         Inc., 901 Sawyer
                                                     Rd., Marietta, GA
                                                     30062.
73-062......................  Loperamide HCl Oral   Watson Laboratories,
                               Solution, 1 mg/5      Inc.
                               mL..
73-106......................  Acetaminophen         Able Laboratories,
                               Suppositories USP,    Inc.,6 Hollywood
                               120 mg..              Ct., South
                                                     Plainfield, NJ
                                                     07080.
73-107......................  Acetaminophen         Do.
                               Suppositories USP,
                               325 mg..
73-108......................  Acetaminophen         Do.
                               Suppositories USP,
                               650 mg..
73-120......................  Albuterol Tablets     Medeva
                               USP, 2 mg..           Pharmaceuticals,
                                                     Inc., 3501 West
                                                     Garry Ave., Santa
                                                     Ana, CA 92704.
73-121......................  Albuterol Tablets     Do.
                               USP, 4 mg..
73-165......................  Albuterol Sulfate     Watson Laboratories,
                               Syrup, 2 mg/5 mL..    Inc.
73-381......................  Carbidopa and         Do.
                               Levodopa Tablets
                               USP, 10 mg/100 mg..
73-382......................  Carbidopa and         Do.
                               Levodopa Tablets
                               USP, 25 mg/100 mg..
73-383......................  Carbidopa and         Do.
                               Levodopa Tablets
                               USP, 25 mg/250 mg..
73-651......................  Piroxicam Capsules    Roxane Laboratories,
                               USP,10 mg and 20      Inc., P.O. Box
                               mg..                  16532, Columbus, OH
                                                     43216.
74-156......................  Gemfibrozil Tablets   Watson Laboratories,
                               USP, 600 mg..         Inc.
74-199......................  Alprazolam Tablets    Roxane Laboratories,
                               USP, 0.25 mg, 0.5     Inc.
                               mg, and 1 mg..
74-319......................  Naproxen Sodium       Purepac
                               Tablets USP..         Pharmaceutical Co.,
                                                     200 Elmora Ave.,
                                                     Elizabeth, NJ
                                                     07207.
74-570......................  Acyclovir Capsules    Roxane Laboratories,
                               USP, 200 mg..         Inc.
74-897......................  Acyclovir Sodium for  Apothecon, Inc.,
                               Injection, USP..      P.O. Box
                                                     4500,Princeton, NJ
                                                     08543.
74-972......................  Cimetidine Tablets    L. Perrigo Co.,515
                               USP, 100 mg..         Eastern Ave.,
                                                     Allegan, MI 49010.
80-109......................  Sulfisoxazole         Impax Laboratories,
                               Tablets USP, 500      Inc., 30831
                               mg..                  Huntwood Ave.,
                                                     Hayward, CA 94544.
80-782......................  Prednisone Tablets    Do.
                               USP, 5 mg..
83-080......................  Aquasol A (Vitamin A  AstraZeneca.
                               Capsules USP)..
83-857......................  Estratab Esterified   Solvay
                               Estrogens Tablets     Pharmaceuticals,
                               USP, 2.5 mg..         Inc.
84-574......................  Aminophylline         Impax Laboratories,
                               Tablets, 100 mg..     Inc.
84-576......................  Aminophylline         Do.
                               Tablets, 200 mg..
84-922......................  Hydralazine HCl       Do.
                               Tablets USP, 25 mg..
85-171......................  Glutethimide Tablets  Medeva
                               USP, 500 mg..         Pharmaceuticals,
                                                     Inc.
85-264......................  Bronkodyl             Sanofi-Synthelabo,
                               (Theophylline         Inc., 90 Park Ave.,
                               Capsules USP), 100    6th Fl., New York,
                               mg and 200 mg..       NY 10016.
85-376......................  Dexamethasone         Impax Laboratories,
                               Tablets USP, 0.75     Inc.
                               mg..

[[Page 41031]]

 
85-544......................  Diethylpropion HCl    Medeva
                               Tablets USP, 25 mg..  Pharmaceuticals,
                                                     Inc.
85-864......................  Amitriptyline HCl     Do.
                               Tablets USP, 10 mg..
85-935......................  Amitriptyline HCl     Do.
                               Tablets USP, 25 mg..
85-936......................  Amitriptyline HCl     Do.
                               Tablets USP, 50 mg..
86-335......................  Amitriptyline HCl     Do.
                               Tablets USP, 150
                               mg..
86-336......................  Amitriptyline HCl     Do.
                               Tablets USP, 100
                               mg..
86-337......................  Amitriptyline HCl     Do.
                               Tablets USP, 75 mg..
87-156......................  Fluonid               Allergan, 2525
                               (Fluocinolone         Dupont Dr., P.O.
                               Acetonide) Cream,     Box 19534, Irvine,
                               0.025%..              CA 92623.
87-157......................  Fluonid               Do.
                               (Fluocinolone
                               Acetonide)
                               Ointment, 0.025%..
88-075......................  Amitriptyline HCl     Purepac
                               Tablets, 10 mg..      Pharmaceutical Co.
88-076......................  Amitriptyline HCl     Do.
                               Tablets, 25 mg..
88-077......................  Amitriptyline HCl     Do.
                               Tablets, 50 mg..
88-078......................  Amitriptyline HCl     Do.
                               Tablets, 75 mg..
88-079......................  Amitriptyline HCl     Do.
                               Tablets, 100 mg..
88-215......................  Penecort              Allergan
                               (Hydrocortisone)
                               Gel, 1%..
88-217......................  Penecort              Do.
                               (Hydrocortisone)
                               Ointment, 2.5%..
89-495......................  Hydrocortisone        Beta Dermaceuticals,
                               Lotion USP, 1%..      Inc., P.O. Box
                                                     691106, San
                                                     Antonio, TX 78269.
------------------------------------------------------------------------

    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 applications listed in the table in this document, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
September 5, 2001.

    Dated: July 24, 2001.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-19509 Filed 8-3-01; 8:45 am]
BILLING CODE 4160-01-S