[Federal Register Volume 64, Number 118 (Monday, June 21, 1999)]
[Notices]
[Pages 33098-33100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-15660]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1818]


Steris Laboratories, Inc.; Withdrawal of Approval of 55 
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 55 abbreviated new drug applications (ANDA's). Steris 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withdrawn.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: Steris Laboratories, Inc., 620 North 51st 
Ave., Phoenix, AZ 85043-4705, 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. Steris Laboratories, 
Inc., has also, by its request, waived its opportunity for a hearing.

[[Page 33099]]



 
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                  ANDA No.                                                   Drug
----------------------------------------------------------------------------------------------------------------
40-043                                       Edrophonium Chloride Injection USP, 10 milligrams (mg)/milliliter
                                              (mL)
40-044                                       Edrophonium Chloride Injection USP, 10 mg/mL
62-788                                       Neomycin and Polymyxin B Sulfate and Gramicidin Ophthalmic Solution
62-900                                       Clindamycin Phosphate Injection USP, 150 mg/mL
63-079                                       Clindamycin Phosphate Injection USP, 150 mg/mL
70-019                                       Furosemide Injection USP, 10 mg/mL
70-170                                       Metronidazole Injection, 500 mg
70-604                                       Furosemide Injection USP, 10 mg/mL
70-713                                       Haloperidol Injection USP, 5 mg/mL
70-744                                       Haloperidol Injection USP, 5 mg/mL
70-911                                       Diazepam Injection, 5 mg/mL (ampule)
70-930                                       Diazepam Injection USP, 5 mg/mL (syringe)
71-556                                       Sulfamethoxazole and Trimethoprim for Injection Concentrate USP, 80
                                              mg/mL and 15 mg/mL
71-339                                       Naloxone Hydrochloride Injection USP, 0.4 mg/mL
73-488                                       Fentanyl Citrate Injection USP, 50 micrograms (mcg)/mL
73-520                                       Droperidol Injection USP, 2.5 mg/mL
73-521                                       Droperidol Injection USP, 2.5 mg/mL
73-523                                       Droperidol Injection USP, 2.5 mg/mL
74-228                                       Etoposide Injection, 20 mg/mL
83-362                                       Prednisolone Tebutate Suspension, 20 mg/mL
83-702                                       Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL
83-767                                       Prednisolone Acetate Suspension, 40 mg/mL
83-820                                       Brompheniramine Maleate Injection, 100 mg/mL
84-510                                       Promazine Hydrochloride Injection USP, 25 mg/mL
84-517                                       Promazine Hydrochloride Injection USP, 50 mg/mL
84-737                                       Hydrocortisone Sodium Succinate for Injection USP, 250 mg
84-738                                       Hydrocortisone Sodium Succinate for Injection USP, 100 mg
84-747                                       Hydrocortisone Sodium Succinate for Injection USP, 500 mg
84-748                                       Hydrocortisone Sodium Succinate for Injection USP, 1000 mg
84-875                                       Mersalyl-Theophylline Injection
85-237                                       Sterile Estrone Suspension USP, 2 mg/mL
85-434                                       Phenytoin Sodium Injection USP, 50 mg/mL
85-490                                       Testosterone Propionate Injection, 25 mg/mL and 50 mg/mL
85-594                                       Amitriptyline Hydrochloride Injection USP, 10 mg/mL
85-599                                       Testosterone Enanthate Injection USP, 100 mg/mL
85-606                                       Dexamethasone Sodium Phosphate Injection USP, 24 mg/mL
86-208                                       Potassium Chloride Injection
86-210                                       Potassium Chloride Injection
86-386                                       Nandrolone Phenpropionate Injection USP, 25 mg/mL
86-947                                       Glycopyrrolate Injection USP, 0.2 mg/mL
86-953                                       Methylprednisolone Sodium Succinate for Injection, 40 mg
87-030                                       Methylprednisolone Sodium Succinate for Injection, 125 mg
87-079                                       Procainamide Hydrochloride Injection USP, 100 mg/mL
87-080                                       Procainamide Hydrochloride Injection USP, 500 mg/mL
87-460                                       Mannitol Injection USP, 250 mg/mL
87-488                                       Nandrolone Phenpropionate Injection USP, 50 mg/mL
88-523                                       Methylprednisolone Sodium Succinate for Injection, 500 mg
88-524                                       Methylprednisolone Sodium Succinate for Injection, 1000 mg
88-554                                       Nandrolone Decanoate Injection, 50 mg/mL
88-772                                       Corticotropin for Injection USP, 40 units (vial)
89-163                                       Potassium Chloride for Injection Concentrate USP, 2
                                              milliequivalents (mEq)/mL
89-170                                       Dexamethasone Ophthalmic Suspension USP, 0.1%
89-171                                       Tropicamide Ophthalmic Solution USP, 0.5%
89-421                                       Potassium Chloride Injection USP, 2 mEq/mL
89-606                                       Prochlorperazine Edisylate Injection USP, 5 mg
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[[Page 33100]]

    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. 99-15660 Filed 6-18-99; 8:45 am]
BILLING CODE 4160-01-F