Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices 63347

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0035]

Ashland Chemical Co.; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 6A4490) proposing that the food

additive regulations be amended to

provide for the safe use of

polypropylene glycol with a molecular

weight of 1,200 to 3,000 as a defoaming

agent in water for sliced potatoes.

FOR FURTHER INFORMATION CONTACT:

Vivian M. Gilliam, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3167.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

February 3, 1997 (62 FR 5011), FDA

announced that a food additive petition

(FAP 6A4490) had been filed by

Ashland Chemical Co., One Drew Plaza,

Boonton, NJ 07005. The petition

proposed to amend the food additive

regulations in § 173.340 Defoaming

agents (21 CFR 173.340) to provide for

the safe use of polypropylene glycol

with a molecular weight of 1,200 to

3,000 as a component of defoaming

agents in wash water for sliced potatoes.

Ashland Chemical Co. has now

withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: November 10, 1997.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval.

[FR Doc. 97–31215 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0479]

Parke-Davis et al.; Withdrawal of

Approval of 18 New Drug Applications,

7 Abbreviated Antibiotic Applications,

and 53 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 18 new drug applications

(NDA’s), 7 abbreviated antibiotic

applications (AADA’s), and 53

abbreviated new drug applications

(ANDA’s). 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withdrawn.

EFFECTIVE DATE: December 29, 1997.

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: 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.

Application No. Drug Applicant

NDA 6–413 ............................................. Super Anahist (neohetramine hydrochloride) ........ Parke-Davis, 2800 Plymouth Rd., Ann Arbor, MI

48105.

NDA 7–812 ............................................. Inhiston-APC (aspirin 3.5 grains (gr), caffeine 0.5

gr, phenacetin 2.5 gr, pheniramine maleate 10

milligrams (mg).

Plough, Inc., P.O. Box 377, Memphis, TN 38151.

NDA 9–108 ............................................. Rauval (rauwolfia serpentina) Tablets ................... Glenwood-Palisades, P.O. Box 369, One New

England Ave., Piscataway, NY 08855.

NDA 11–760 ........................................... Normacol (polycarbophil) Tablets .......................... Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NY 07033.

NDA 11–935 ........................................... Actifed (pseudoephedrine hydrochloride and

triprolidine hydrochloride) Syrup.

Glaxo Wellcome Inc., Five Moore Dr., Research

Triangle Park, NC 27709.

NDA 11–936 ........................................... Actifed (pseudoephedrine hydrochloride and

triprolidine hydrochloride) Tablets.

Do.

NDA 11–950 ........................................... Tacaryl (methdilazine hydrochloride) Syrup, 4 mg/

15 milliliters (mL).

Westwood-Squibb Pharmaceuticals, Inc., 100 Forest Ave., Buffalo, NY 14213–1091.

NDA 12–939 ........................................... Neutrapen (penicillinase injectable) ....................... 3M Pharmaceuticals, Bldg. 260–6A–22, 3M Center, St. Paul, MN 55144–1000.

NDA 15–438 ........................................... Meprobamate Tablets USP, 200 mg, 400 mg ....... Zenith Goldline Pharmaceuticals, 140 Legrand

Ave., Northvale, NJ 07647.

NDA 16–649 ........................................... Feminone Tablets .................................................. Pharmacia & Upjohn, 7000 Portage Rd., Kalamazoo, MI 49001–0199.

NDA 17–369 ........................................... Teldrin (chlorpheniramine maleate extended release) Spansules.SmithKline Beecham Consumer Healthcare, 1500

Littleton Rd., Parsippany, NY 07054–3884.

NDA 17–906 ........................................... Lactulose Syrup ..................................................... Solvay Pharmaceuticals, Inc., 901 Sawyer Rd.,

Marietta, GA 30062.

NDA 19–014 ........................................... Benylin Decongestant Cough Formula

(diphenhydramine hydrocholoride and

pseudoephedrine hydrochloride).

Warner-Lambert Co., 170 Tabor Rd., Morris

Plains, NJ 07950.

NDA 50–125 ........................................... Tablets Remanden-250 (Potassium Penicillin G

with Probenecid).

Merck & Co., Inc., BLA–30, West Point, PA

19486.

NDA 50–137 ........................................... Cer-O-Cillin Sodium (crystalline sodium penicillin

O).

Pharmacia & Upjohn
63348 Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices

Application No. Drug Applicant

NDA 50–298 ........................................... Pyopen (sterile carbenicillin disodium) Injection .... SmithKline Beecham Pharmaceuticals, P.O. Box

7929, Philadelphia, PA 19101–7929.

NDA 50–375 ........................................... Cremomycin Oral Suspension ............................... Merck & Co., Inc.

NDA 50–566 ........................................... Sterile Cefazolin Sodium Injection in PL146 Plastic Container.Baxter Healthcare Corp., Rt. 120 and Wilson Rd.,

Round Lake, IL 60073–0490.

AADA 60–571 ........................................ MYCOSTATIN (Nystatin) Ointment 100,000 USP

units per gram (g).

Westwood-Squibb Pharmaceuticals, Inc.

AADA 60–634 ........................................ Oxytetracycline Hydrochloride Capsules USP, 250

mg.

Purepac Pharmaceutical Co., 200 Elmora Ave.,

Elizabeth, NJ 07207.

AADA 62–471 ........................................ Gentamicin Sulfate Cream, USP 0.1% .................. Alpharma, U.S. Pharmaceuticals Div., Johns Hopkins Bayview Center, 333 Cassell Dr., suite

3500, Baltimore, MD 21224.

AADA 62–496 ........................................ Gentamicin Sulfate Ointment, USP 0.1% .............. Do.

AADA 62–583 ........................................ Bacitracin (sterile) .................................................. Alpharma AS, U.S. Agent: Alpharma Inc., One

Executive Dr., P.O. Box 1399, Fort Lee, NJ

07024.

AADA 62–584 ........................................ Bacitracin Zinc (nonsterile) .................................... Do.

AADA 63–250 ........................................ Amoxicillin Trihydrate, nonsterile bulk ................... Ranbaxy Laboratories Ltd., U.S. Agent: Ranbaxy

Pharmaceuticals, Inc., 4600 Marriott Dr., suite

100, Raleigh, NC 27612.

ANDA 70–136 ........................................ Propranolol Hydrochloride Injection USP, 1 mg/

mL (syringe).

SoloPak Laboratories, 1845 Tonne Rd., Elk

Grove Village, IL 60007–5125.

ANDA 70–579 ........................................ Allopurinol Tablets USP, 100 mg .......................... Purepac Pharmaceutical Co.

ANDA 70–688 ........................................ Methyldopa and Hydrochlorothiazide Tablets

USP, 250 mg/25 mg.

Do.

ANDA 70–695 ........................................ Verapamil Hydrochloride Injection USP, 2.5 mg/

mL (syringe).

SoloPak Laboratories

ANDA 70–800 ........................................ Haloperidol Injection USP, 5 mg/mL (syringe) ...... Do.

ANDA 70–853 ........................................ Methyldopa and Hydrochlorothiazide Tablets

USP, 250 mg/15 mg.

Purepac Pharmaceutical Co.

ANDA 70–854 ........................................ Methyldopa and Hydrochlorothiazide Tablets

USP, 250 mg/30 mg.

Do.

ANDA 71–000 ........................................ Amantadine Hydrochloride Capsules USP, 100

mg.

Solvay Pharmaceuticals, Inc.

ANDA 71–123 ........................................ Ibuprofen Tablets USP, 300 mg ............................ Purepac Pharmaceutical Co.

ANDA 71–124 ........................................ Ibuprofen Tablets USP, 400 mg ............................ Do.

ANDA 71–125 ........................................ Ibuprofen Tablets USP, 600 mg ............................ Do.

ANDA 71–672 ........................................ Naloxone Hydrochloride Injection USP, 0.02 mg/

mL (syringe).

SoloPak Laboratories

ANDA 71–683 ........................................ Naloxone Hydrochloride Injection USP, 0.4 mg/

mL (syringe).

Do.

ANDA 72–110 ........................................ Doxepin Hydrochloride Capsules USP, 100 mg .... Purepac Pharmaceutical Co.

ANDA 72–330 ........................................ Clorazepate Dipotassium Tablets, 3.75 mg ........... Do.

ANDA 72–331 ........................................ Clorazepate Dipotassium Tablets, 7.5 mg ............. Do.

ANDA 72–332 ........................................ Clorazepate Dipotassium Tablets, 15 mg .............. Do.

ANDA 72–386 ........................................ Doxepin Hydrochloride Capsules USP, 75 mg ...... Do.

ANDA 72–387 ........................................ Doxepin Hydrochloride Capsules USP, 150 mg .... Do.

ANDA 80–493 ........................................ Cortisone Acetate Tablets USP, 25 mg ................ Do.

ANDA 80–842 ........................................ Rauwolfia Serpentina Tablets USP, 50 mg and

100 mg.

Do.

ANDA 80–845 ........................................ Diphenhydramine Hydrochloride Capsules USP,

25 mg and 50 mg.

Eon Labs Manufacturing, Inc., 227–15 North Conduit Ave., Laurelton, NY 11413.

ANDA 84–138 ........................................ Phendimetrazine Tartrate Tablets, 35 mg (Pink) ... KV Pharmaceutical Co., 2503 South Hanley Rd.,

St. Louis, MO 63144–2555.

ANDA 84–141 ........................................ Phendimetrazine Tartrate Tablets, 35 mg ............. Do.

ANDA 84–479 ........................................ Dicyclomine Hydrochloride Syrup USP, 10 mg/5

mL.

Alpharma, U.S. Pharmaceuticals Div.

ANDA 84–932 ........................................ Quinidine Sulfate USP, 200 mg (Tablets) ............. Solvay Pharmaceuticals, Inc.

ANDA 85–296 ........................................ Quinidine Sulfate USP, 200 mg (Capsules) .......... Do.

ANDA 85–297 ........................................ Quinidine Sulfate USP, 300 mg (Capsules) .......... Do.

ANDA 85–298 ........................................ Quinidine Sulfate USP, 300 mg (Tablets) ............. Do.

ANDA 85–299 ........................................ Quinidine Sulfate USP, 100 mg (Tablets) ............. Do.

ANDA 86–298 ........................................ UNIPRES (Reserpine, Hydralazine Hydrochloride,

and Hydrochlorothiazide Tablets, USP) 0.1 mg/

25 mg/15 mg.

Do.

ANDA 86–822 ........................................ Hydroxyzine Hydrochloride Injection USP, 25 mg/

mL (syringe).

SoloPak Laboratories

ANDA 87–043 ........................................ Heparin Sodium Injection USP, 1,000 units/mL

(syringe).

Do.

ANDA 87–077 ........................................ Heparin Sodium Injection USP, 5,000 units/mL

(syringe).

Do.

ANDA 87–101 ........................................ Isoetharine Inhalation Solution, USP 1% .............. Alpharma, U.S. Pharmaceuticals Div.
Federal Register / Vol. 62, No. 229 / Friday, November 28, 1997 / Notices 63349

Application No. Drug Applicant

ANDA 87–107 ........................................ Heparin Sodium Injection USP, 10,000 units/mL

(syringe).

SoloPak Laboratories

ANDA 87–109 ........................................ Nitroglycerin Extended-Release Capsules, 9 mg .. KV Pharmaceutical Co.

ANDA 87–310 ........................................ Hydroxyzine Hydrochloride Injection USP, 50 mg/

mL.

SoloPak Laboratories

ANDA 87–344 ........................................ Isosorbide Dinitrate Extended-release Capsules,

40 mg.

Inwood Laboratories, Inc., 909 Third Ave., New

York, NY 10022–4731.

ANDA 87–363 ........................................ Heparin Sodium Injection USP, 10,000 units/0.5

mL (syringe).

SoloPak Laboratories

ANDA 87–395 ........................................ Heparin Sodium Injection USP, 5,000 units/0.5

mL (syringe).

Do.

ANDA 87–551 ........................................ Cyanocobalamin Injection USP, 1,000

micrograms/mL (syringe).

Do.

ANDA 87–596 ........................................ Hydroxyzine Hydrochloride Injection USP, 50 mg/

mL and 100 mg/mL.

Do.

ANDA 87–903 ........................................ Heparin Lock Flush Solution USP, 10 units/mL

(syringe).

Do.

ANDA 87–905 ........................................ Heparin Lock Flush Solution USP, 100 units/mL

(syringe).

Do.

ANDA 88–120 ........................................ Hydroxyzine Hydrochloride Tablets USP, 10 mg .. Purepac Pharmaceutical Co.

ANDA 88–121 ........................................ Hydroxyzine Hydrochloride Tablets USP, 25 mg .. Do.

ANDA 88–122 ........................................ Hydroxyzine Hydrochloride Tablets USP, 50 mg .. Do.

ANDA 88–139 ........................................ Chlorthalidone Tablets USP, 25 mg ...................... Do.

ANDA 88–177 ........................................ Hydralazine Hydrochloride Tablets, 25 mg ............ Do.

ANDA 88–520 ........................................ Phenytoin Sodium Injection USP, 50 mg/mL (syringe).SoloPak Laboratories

ANDA 88–532 ........................................ Procainamide Hydrochloride Injection USP, 500

mg/mL (syringe).

Do.

ANDA 89–094 ........................................ Trimethobenzamide Hydrochloride Injection USP,

100 mg/mL (syringe).

Do.

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

December 29, 1997.

Dated: November 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–31214 Filed 11–26–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0451]

Microbial Safety of Produce;

Grassroots and International Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing six

grassroots meetings and one

international meeting to discuss

generally the President’s recently

announced initiative to ensure the

safety of imported and domestic fruits

and vegetables and other foods, and

specifically the microbial safety of

produce. The meetings are intended to

give an overview of, and obtain input on

the general draft guide entitled ‘‘Guide

to Minimizing Microbial Food Safety

Hazards for Fresh Fruit and Vegetables.’’

DATES AND TIME: For the domestic

meetings see Table 1 in the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document. For the

international meeting see Table 2.

Submit written comments by December

19, 1997. All the meetings will be held

from 9 a.m. to 4 p.m.

ADDRESSES: For the domestic meetings

see Table 1 in the ‘‘SUPPLEMENTARY

INFORMATION’’ section of this

document. For the international meeting

see Table 2. Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Copies

of the ‘‘Guide to Minimizing Microbial

Food Safety Hazards for Fresh Fruit and

Vegetables’’ may be obtained from Joan

E. Duy, Center for Food Safety and

Applied Nutrition (HFS–335), Food and

Drug Administration, 200 C St. SW., rm.

3812, Washington, DC 20204, 202–260–

8920, FAX 202–205–4422, e-mail

jduy@bangate.fda.gov.

FOR FURTHER INFORMATION CONTACT: For

general information on this document:

Camille E. Brewer, Center for Food

Safety and Applied Nutrition (HFS–

165), Food and Drug Administration,

200 C St. SW., rm. 3169, Washington,

DC, 202–260–8920, FAX 202–205–4422,

e-mail ceb@cfsan.fda.gov. Send

registration information (including

name, title, firm name, mailing address,

telephone number and fax number if

appropriate) to the contact person listed

for the city in which you will attend.

SUPPLEMENTARY INFORMATION: On

October 2, 1997, the President

announced an initiative to ensure the

safety of imported and domestic

produce and other foods. This initiative

is geared to optimize the microbial

safety of domestic and imported fresh

fruits and vegetables. As part of this

initiative, the President directed the

Secretary of the Department of Health

and Human Services (DHHS), in

partnership with the Secretary of the

Department of Agriculture (USDA), and

in cooperation with the agricultural

community, to issue advice on good

agricultural practices and good

manufacturing practices for fresh fruits

and vegetables. FDA will coordinate the

effort for DHHS. As part of this effort,

FDA plans to publish for public