[Federal Register Volume 67, Number 34 (Wednesday, February 20, 2002)]
[Notices]
[Pages 7702-7703]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0035]


Mylan Pharmaceuticals et al.; Withdrawal of Approval of 34 
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 34 abbreviated new drug applications (ANDAs). The holders of the 
applications notified the agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective March 22, 2002.

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
------------------------------------------------------------------------
  61-530          Penicillin V Potassium      Mylan Pharmaceuticals,
                   Tablets USP, 250            Inc., 781 Chestnut Ridge
                   milligrams (mg) and 500     Rd., P.O. Box 4310
                   mg.                         Morgantown, WV 26504-
                                               4310.
  61-829          Ampicillin for Oral         Do.
                   Suspension USP, 125 mg/5
                   milliliters (mL) and
                   250mg/5 mL.
  62-067          Amoxicillin Capsules USP,   Do.
                   250 mg and 500 mg
  62-104          Neomycyin Sulfate with      Clay-Park Laboratories,
                   Hydrocortisone Ointment     Inc., 1700 Bathgate Ave.,
                   USP, 0.35% and 1%.          Bronx, NY 10457.
  62-280          Nystatin and Triamcinolone  Do.
                   Acetonide Ointment USP
  62-372          Mezlin (sterile             Bayer Corp. Pharmaceutical
                   mezlocillin sodium)         Division, 400 Morgan
                                               Lane, West Haven, CT
                                               06516.
  62-697          Mezlin (sterile             Do.
                   mezlocillin sodium)
  71-099          Bromatapp ER                Copley Pharmaceuticals,
                   (brompheniramine maleate/   Inc., 25 John Rd. Canton,
                   phenylpropanolamine         MA 02021.
                   hydrochloride (HCl))
                   Extended-Release Tablets,
                   12 mg/75 mg.
  71-551          Flurazepam HCl Capsules     Purepac Pharmaceutical
                   USP, 30 mg                  Co., 200 Elmora Ave.,
                                               Elizabeth, NJ 07207.
  71-927          Flurazepam HCl Capsules     Do.
                   USP, 15 mg
  72-027          Fentanyl Citrate and        AstraZeneca LP, 1800
                   Droperidol Injection        Concord Pike, P.O. Box
                                               8355, Wilmington, DE
                                               19803-8355.
  72-070          Nalbuphine HCl Injection    Do.
                   USP, 10 mg/mL
  72-073          Nalbuphine HCl Injection    Do.
                   USP, 20 mg/mL
  72-921          Prazosin HCl Capsules USP,  Purepac Pharmaceutical Co.
                   2 mg
  72-991          Prazosin HCl Capsules USP,  Do.
                   1 mg
  72-992          Prazosin HCl Capsules USP,  Do.
                   5 mg
  73-690          Calcitonin-Salmon           AstraZeneca LP.
                   Injection, 200
                   international units/mL

[[Page 7703]]

 
  74-579          Betamethasone Dipropionate  Clay-Park Laboratories,
                   Cream USP, 0.05% (base)     Inc.
  75-263          Midazolam HCl Injection, 5  AstraZeneca LP.
                   mg (base)/mL
  75-348          Ketorolac Tromethamine      Apothecon, Inc., P.O. Box
                   Injection USP, 15 mg/mL     4500, Princeton, NJ 08543-
                   and 30 mg/mL.               4500.
  75-355          Labetalol HCl Injection     Do.
                   USP, 5 mg/mL
  75-620          Midazolam HCl Injection, 1  Do.
                   mg (base)/mL and 5 mg
                   (base)/mL.
  75-641          Midazolam HCl Injection, 5  Do.
                   mg (base)/mL
  75-642          Bisoprolol Fumarate and     Do.
                   Hydrochlorothiazide
                   Tablets
  75-707          Famotidine Injection, 10    Do.
                   mg/mL
  75-708          Famotidine Injection, 10    Do.
                   mg/mL (preservative free)
  83-115          Niacin Tablets USP, 500 mg  Impax Laboratories, Inc.,
                                               30831 Huntwood Ave.,
                                               Hayward, CA 94544.
  84-968          Nitrofurazone Ointment      Clay-Park Laboratories,
                   USP, 0.2%                   Inc.
  85-130          Nitrofurazone Topical       Do.
                   Solution USP, 0.2%
  86-424          Triple Sulfa Vaginal Cream  Altana Inc., 60 Baylis
                                               Rd., Melville, NY 11747.
  86-810          Fluocinolone Acetonide      Clay-Park Laboratories,
                   Cream USP, 0.01%            Inc.
  86-811          Fluocinolone Acetonide      Do.
                   Cream USP, 0.025%
  89-784          Meperidine HCl Injection    AstraZeneca LP.
                   USP, 50 mg/mL
  89-788          Meperidine HCl Injection    Do.
                   USP, 1,000 mg/mL
------------------------------------------------------------------------

    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 
March 22, 2002.

    Dated: February 12, 2002.
Steven K. Galson,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 02-4091 Filed 2-19-02; 8:45 am]
BILLING CODE 4160-01-S