[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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withdrawn.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]]
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
[[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
