[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that the approval of the applications be withdrawn.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
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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