[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Pages 33097-33098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1833]


SoloPak Laboratories, Inc.; Withdrawal of Approval of 1 New Drug 
Application and 38 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 1 new drug application (NDA) and 38 abbreviated new drug 
applications (ANDA's). SoloPak Laboratories, Inc., 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that the approval of the applications be withdrawn.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: July 21, 1999.

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

SUPPLEMENTARY INFORMATION: SoloPak Laboratories, Inc., 1845 Tonne Rd., 
Elk Grove Village, IL 60007-5125, has informed FDA that the drug 
products listed in the following table are no longer marketed and has 
requested that FDA withdraw approval of the applications. SoloPak 
Laboratories, Inc.,

[[Page 33098]]

has also, by its request, waived its opportunity for a hearing.

 
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                    Application No.                                                Drug
----------------------------------------------------------------------------------------------------------------
NDA 19-961                                               Ganite (gallium nitrate)
ANDA 62-507                                              Gentamicin Sulfate Injection USP, 10 and 40 milligrams
                                                          (mg)/milliliter (mL)
ANDA 62-605                                              Kanamycin Sulfate Injection USP, 500 mg/2 mL and 75 mg/
                                                          2 mL and 1 gram/3 mL
ANDA 62-819                                              Clindamycin Phosphate Injection USP, 150 mg/mL
ANDA 62-852                                              Clindamycin Phosphate Injection USP, 150 mg/mL
ANDA 70-046                                              Dopamine Hycrochloride Injection USP, 40 mg/mL
ANDA 70-047                                              Dopamine Hycrochloride Injection USP, 80 mg/mL
ANDA 70-078                                              Furosemide Injection USP, 10 mg/mL
ANDA 70-137                                              Propranolol Hydrochloride Injection USP, 1 mg/mL
ANDA 70-623                                              Metoclopramide Injection USP, 5 mg/mL
ANDA 70-633                                              Nitroglycerin Injection USP, 5 mg/mL
ANDA 70-696                                              Verapamil Hydrochloride Injection USP, 2.5 mg/mL
ANDA 70-801                                              Haloperidol Lactate Injection USP, 5 mg/mL
ANDA 70-841                                              Methyldopate Hydrochloride Injection USP, 50 mg/mL
ANDA 70-864                                              Haloperidol Injection USP, 5 mg/mL
ANDA 71-671                                              Naloxone Hydrochloride Injection USP, 0.02 mg/mL
ANDA 71-681                                              Naloxone Hydrochloride Injection USP, 0.4 mg/mL
ANDA 71-682                                              Naloxone Hydrochloride Injection USP, 0.4 mg/mL
ANDA 71-754                                              Droperidol Injection USP, 2.5 mg/mL
ANDA 71-755                                              Droperidol Injection USP, 2.5 mg/mL
ANDA 87-591                                              Hydroxyzine Hydrochloride Injection USP, 25 mg/mL
ANDA 87-593                                              Hydroxyzine Hydrochloride Injection USP, 50 mg/mL
ANDA 87-595                                              Hydroxyzine Hydrochloride Injection USP, 50 mg/mL
ANDA 88-239                                              Heparin Sodium Injection USP, 1,000 Units/mL
ANDA 88-457                                              Heparin Lock Flush Solution USP, 10 Units/mL
ANDA 88-458                                              Heparin Lock Flush Solution USP, 10 Units/mL
ANDA 88-459                                              Heparin Lock Flush Solution USP, 100 Units/mL
ANDA 88-460                                              Heparin Lock Flush Solution USP, 100 Units/mL
ANDA 88-517                                              Hydralazine Hydrochloride Injection USP, 20 mg/mL
ANDA 88-519                                              Phenytoin Sodium Injection USP, 50 mg/mL
ANDA 88-530                                              Procainamide Hydrochloride Injection USP, 100 mg/mL
ANDA 88-531                                              Procainamide Hydrochloride Injection USP, 500 mg/mL
ANDA 88-580                                              Heparin Lock Flush Solution USP, 10 Units/mL
ANDA 88-581                                              Heparin Lock Flush Solution USP, 100 Units/mL
ANDA 88-749                                              Aminophylline Injection USP, 25 mg/mL
ANDA 88-767                                              Fluorouracil Injection USP, 50 mg/mL
ANDA 88-960                                              Trimethobenzamide Hydrochloride Injection USP, 100 mg/
                                                          mL
ANDA 89-251                                              Prochlorperazine Edisylate Injection USP, 5mg/mL
ANDA 89-434                                              Flourouracil Injection USP, 50 mg/mL
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    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 
July 21, 1999.

    Dated: June 7, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-15581 Filed 6-18-99; 8:45 am]
BILLING CODE 4160-01-F