Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices 20499

genuine and substantial issue of fact

that precludes the withdrawal of

approval of the MFA’s, or that the

request for a hearing is not made in the

required format or with the required

analysis, the Commissioner of Food and

Drugs will enter summary judgment

against the person who requests the

hearing, making findings and

conclusions, and denying a hearing. If a

hearing is requested and is justified by

the sponsor’s response to this notice, the

issues will be defined, an administrative

law judge will be assigned, and a

written notice of the time and place at

which the hearing will begin will be

issued as soon as practicable.

All submissions under this notice

shall be filed in four copies and, except

as provided in 21 CFR 10.20(j), may be

seen in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 512 (21 U.S.C. 360b)) and under

authority delegated to the Director,

Center For Veterinary Medicine (21 CFR

5.84).

Dated: April 19, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–10274 Filed 4–25–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0101]

Warren Teed Pharmaceuticals, Inc., et

al.; Withdrawal of Approval of 107

Abbreviated New Drug Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 107 abbreviated new drug

applications (ANDA’s). The holders of

the ANDA’s 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withdrawn.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: May 26, 1995.

FOR FURTHER INFORMATION CONTACT:

Carolyn C. Harris, Center for Drug

Evaluation and Research (HFD–360),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–1038.

SUPPLEMENTARY INFORMATION: The

holders of the ANDA’s 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.

ANDA No. Drug Applicant

83–076 ........................ Sulfasalazine, 500 milligrams (mg) ..................................... Warren Teed Pharmaceuticals, Inc., Columbus, OH

43215.

83–078 ........................ Chlorpheniramine Maleate Tablets, 4 mg ........................... Anabolic, Inc., P.O. Box C–19508, Irvine, CA 92713.

83–135 ........................ Lidocaine Hydrochloride Injection, U.S.P., 1% and 2% ...... G. D. Searle and Co., P.O. Box 5110, Chicago, IL 60680.

83–168 ........................ Hydrocortisone Liquid, 1% and 2 1/2% ............................... Dermik Laboratories, Inc., 500 Arcola Rd., P.O. Box 1200,

Collegeville, PA 19426–0107.

83–169 ........................ Hydrocortisone Gel, 1% and 2 1/2% ................................... Do.

83–184 ........................ Propoxyphene Hydrochloride Capsules, 65 mg .................. Smith, Kline & French, One Franklin Plaza, P.O. Box

7929, Philadelphia, PA 19101.

83–275 ........................ Diphenhydramine Hydrochloride Capsules, U.S.P., 50 mg Anabolic, Inc.

83–301 ........................ Pentobarbital Sodium Capsules, 100 mg ............................ Purepac Pharmaceutical, Co., 200 Elmora Ave., Elizabeth,

NJ 07207.

83–313 ........................ Triamcinolone Acetonide Ointments, 0.025%, 0.1%, and

0.5%.

Dermik Laboratories, Inc.

83–314 ........................ Triamcinolone Acetonide Creams, 0.025%, 0.1%, and

0.5%.

Do.

83–363 ........................ Metaraminol Bitartrate Injection, U.S.P., 10 mg/milliliters

(mL).

Elkins-Sinn, Inc., Two Esterbrook Lane, Cherry Hill, NJ

08003–4099.

83–554 ........................ Hydrochlorothiazide Tablets, 50 mg .................................... Smith, Kline & French.

83–567 ........................ Diphenhydramine Hydrochloride Capsules, 50 mg ............. West-Ward Pharmaceutical Corp., 465 Industrial Way,

West, Eatontown, NJ 07724.

83–625 ........................ Tripelennamine Hydrochloride Tablets, U.S.P., 25 mg ....... Warner-Lambert, 201 Tabor Rd., Morris Plains, NJ 07950.

83–626 ........................ Tripelennamine Hydrochloride Tablets, U.S.P., 50 mg ....... Do.

84–125 ........................ Dextroamphetamine Sulfate Tablets, 5 mg and 10 mg ...... Purepac Pharmaceutical, Co.

84–239 ........................ Hydrocortisone Tablets, 10 mg ........................................... Warner-Lambert.

84–240 ........................ Prednisone Tablets, 5 mg ................................................... Do.

84–242 ........................ Prednisolone Tablets, 5 mg ................................................ Do.

84–530 ........................ Aminophylline Tablets, 200 mg ........................................... The Vale Chemical Co., Inc., Allentown, PA 18102.

84–531 ........................ Aminophylline Tablets, 100 mg ........................................... Do.

84–601 ........................ Chlordiazepoxide Hydrochloride Capsules, 10 mg ............. Mylan Pharmaceuticals, Inc., P.O. Box 4310, 781 Chestnut Ridge Rd., Morgantown, WV 26505–4310.

84–699 ........................ Aminophylline Tablets, 100 mg ........................................... Purepac Pharmaceutical, Co.

84–739 ........................ Theophylline Elixir, 80 mg/15 mL ........................................ Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus,

OH 43228.

84–880 ........................ Hydrochlorothiazide Tablets, 25 mg and 50 mg ................. Mylan Pharmaceuticals, Inc.

85–112 ........................ Hydrochlorothiazide Tablets, 50 mg .................................... Do.

85–195 ........................ Meclizine Hydrochloride Tablets, 12.5 mg .......................... Circa Pharmaceuticals, 15 Grand Park Blvd., Athens, OH

45701.

85–375 ........................ Acetaminophen Capsules, 500 mg Oxycodone Hydrochloride Capsules, 4.5 mg Oxycodone Terephthalate

Capsules, 0.38 mg.

McNeil Pharmaceutical, Welsh and Mckeon Rds., Spring

House, PA 19477–0776.

85–534 ........................ Sulfisoxazole Tablets, 500 mg ............................................ Chelsea Laboratories, Inc., 896 Orlando Ave., West

Hempstead, NY 11552.

85–564 ........................ Aminophylline Tablets, 200 mg ........................................... Do.

85–567 ........................ Aminophylline Tablets, 100 mg ........................................... Do.
20500 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices

ANDA No. Drug Applicant

85–667 ........................ Hydrocodone Bitartrate Tablets, 5 mg Acetaminophen

Tablets, 500 mg.

Knoll Pharmaceutical, 30 North Jefferson Rd., Whippany,

NJ 07981.

85–867 ........................ Secobarbital Sodium Capsules, U.S.P., 100 mg ................ Purepac Pharmaceutical, Co.

85–892 ........................ Dextroamphetamine Sulfate Tablets, 10 mg ....................... Phoenix Pharmaceutical, Inc., 111 Leuning St., South

Hackensack, NJ 07606.

86–044 ........................ Isosorbide Dinitrate Tablets, 10 mg .................................... Circa Pharmaceuticals.

86–049 ........................ Brompheniramine Maleate Tablets, 4 mg ........................... Purepac Pharmaceutical Co.

86–170 ........................ Hydrocortisone Cream,1% .................................................. Stiefel Laboratories, Inc., 2801 Ponce De Leon Blvd.,

Coral Gables, FL 33134.

86–202 ........................ Procaine Hydrochloride Injection, 1% and 2% .................... G. D. Searle and Co.

86–205 ........................ Ammonium Chloride Injection, 3 milliquivalent (meq)/mL ... Do.

86–219 ........................ Potassium Chloride Injection, U.S.P., 10 meq/10 mL, 20

meq/10 mL, 30 meq/mL, and 40 meq/10 mL.

Do.

86–220 ........................ Potassium Chloride Injection ............................................... G. D. Searle and Co.

86–302 ........................ Isosorbide Dinitrate Tablets, 10 mg .................................... Purepac Pharmaceutical, Co.

86–304 ........................ Isosorbide Dinitrate Tablets, 5 mg ...................................... Do.

86–369 ........................ Hydrochlorothiazide Tablets, 25 mg .................................... Smith, Kline & French.

86–418 ........................ Metaraminol Bitartrate Injection, U.S.P. .............................. McGaw Inc., P.O. Box 19791, Irvine, CA 92713–9791.

86–824 ........................ Hydrocortisone Lotion, 0.5% ............................................... Pharmaceutical Associates, Inc., P.O. Box 128, Conestee,

SC 29636.

86–858 ........................ Isosorbide Dinitrate Tablets, U.S.P., 5 mg .......................... Lederle Labs, One Cyanamid Co., Wayne, NJ 07470–

8426.

86–862 ........................ Isosorbide Dinitrate Tablets, U.S.P., 10 mg ........................ Do.

86–981 ........................ Dipyridamole Tablets, Coated, 25 mg ................................. Circa Pharmaceuticals.

87–085 ........................ Hydralazine Hydrochloride Tablets, 25 mg

Hydrochlorothiazide Tablets, 15 mg Reserpine Tablets,

0.1 mg.

Mylan Pharmaceuticals, Inc.

87–163 ........................ Isosorbide Dinitrate Chewable Tablets, 5 mg ..................... D. M. Graham Laboratories, Inc., Hobart, NY 13788.

87–415 ........................ Isosorbide Dinitrate Capsules T.R., 40 mg, Green & Clear Eon Labs Manufacturing, Inc., 227–15 North Conduit Ave.,

Laurelton, NY 11413.

87–474 ........................ Isosorbide Dinitrate Oral Tablets, 5 mg .............................. Ascot Hospital Pharmaceuticals, Inc., 8055 North Ridgeway Ave., Skokie, IL 60076.

87–475 ........................ Isosorbide Dinitrate Oral Tablets, 10 mg ............................ Do.

87–476 ........................ Isosorbide Dinitrate Oral Tablets, 20 mg ............................ Do.

87–478 ........................ Isosorbide Dinitrate Sublinqual Tablets, 5 mg .................... Do.

87–484 ........................ Nitroglycerine TD Capsules, 2.5 mg ................................... Do.

87–485 ........................ Nitroglycerine TD Capsules, 6.5 mg ................................... Do.

87–486 ........................ Isosorbide Dinitrate SR Capsules, 40 mg ........................... Do.

87–512 ........................ Chlordiazepoxide Hydrochloride Capsules, 25 mg ............. Do.

87–514 ........................ Triprolidine Hydrochloride Syrup, 1.25 mg/5 mL ................ Pharmaceutical Associates, Inc.

87–517 ........................ Brompheniramine Maleate Elixir, 2 mg/5 mL ...................... Do.

87–518 ........................ Promethazine Hydrochloride Syrup, 6.25 mg/5 mL ............ Do.

87–520 ........................ Chlorpheniramine Maleate Syrup, 2 mg/5 mL .................... Do.

87–522 ........................ Aminophylline Tablets, 100 mg ........................................... Ascot Hospital Pharmaceuticals, Inc.

87–523 ........................ Aminophylline Tablets,200 mg ............................................ Do.

87–524 ........................ Chlordiazepoxide Hydrochloride Capsules, 10 mg ............. Do.

87–525 ........................ Chlordiazepoxide Hydrochloride Capsules, 5 mg ............... Do.

87–539 ........................ Hydrochlorothiazide Tablets, 25 mg .................................... Do.

87–540 ........................ Hydrochlorothiazide Tablets, 50 mg .................................... Do.

87–541 ........................ Tolbutamide Tablets, 500 mg .............................................. Do.

87–542 ........................ Procainamide Hydrochloride Capsules, 250 mg ................. Do.

87–543 ........................ Procainamide Hydrochloride Capsules, 500 mg ................. Do.

87–621 ........................ Aminophylline Injection, 25 mg/mL ..................................... G. D. Searle and Co.

87–660 ........................ Methocarbamol Tablets, 500 mg ......................................... Ascot Hospital Pharmaceuticals, Inc.

87–661 ........................ Methocarbamol Tablets,750 mg .......................................... Do.

87–662 ........................ Sulfamethoxazole Tablets, 500 mg ..................................... Do.

87–663 ........................ Propantheline Bromide Tablets, 15 mg ............................... Do.

87–685 ........................ Cyproheptadine Hydrochloride Tablets, 4 mg ..................... Do.

87–686 ........................ Acetazolamide Tablets, 250 mg .......................................... Do.

87–687 ........................ Spironolactone Tablets,25 mg ............................................. Do.

87–697 ........................ Procainamide Hydrochloride Capsules, 375 mg ................. Do.

87–698 ........................ Chlorthalidone Tablets, 25 mg ............................................ Do.

87–699 ........................ Chlorthalidone Tablets, 50 mg ............................................ Do.

87–734 ........................ Nitroglycerin Oral Transmucosal Long Acting Tablets, 1

mg.

Merrell Dow Pharmaceuticals, Inc., 2110 East Galbraith

Rd., P.O. Box 156300, Cincinnati, OH 45215–6300.

87–778 ........................ Dimenhydrinate Tablets, 50 mg .......................................... Republic Drug Co., Inc., 175 Great Arrow Ave., Buffalo,

NY 14207.

87–934 ........................ Diphenoxylate Hydrochloride Tablets, 2.5 mg Atropine

Sulfate Tablets, 0.025 mg.

Ascot Hospital Pharmaceuticals, Inc.

88–005 ........................ Isosorbide Dinitrate Sublingual Tablets, 5 mg .................... Unit Dose Laboratories, 1718 Northrock Court, Rockford,

IL 61103.

88–006 ........................ Isosorbide Dinitrate Tablets, Oral, 10 mg ........................... Do.

88–025 ........................ Spironolactone with Hydrochlorothiazide Tablets, 25 mg/

25 mg.

Ascot Hospital Pharmaceuticals, Inc.
Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices 20501

ANDA No. Drug Applicant

88–067 ........................ Orphenadrine Citrate S. R. Tablets, 100 mg ...................... Do.

88–117 ........................ Triprolidine Hydrochloride Tablets, 2.5 mg

Pseudoephedrine Hydrochloride Tablets, 60 mg.

West-Ward Pharmaceutical Corp.

88–199 ........................ Folic Acid Tablets, 1 mg ...................................................... Unit Dose Laboratories.

88–256 ........................ Meclizine Hydrochloride Tablets, 12.5 mg .......................... Do.

88–257 ........................ Meclizine Hydrochloride Tablets, 25 mg ............................. Do.

88–288 ........................ Bethanechol Chloride Tablets, 10 mg ................................. Ascot Hospital Pharmaceuticals, Inc.

88–289 ........................ Bethanechol Chloride Tablets, 25 mg ................................. Do.

88–307 ........................ Thioridazine Hydrochloride Oral Concentrate, 30 mg/milliliters (mL).Geneva Pharmaceuticals, Inc., 2555 West Midway Blvd.,

Broomfield, CO 80038–0446.

88–308 ........................ Thioridazine Hydrochloride Oral Concentrate, 100 mg/mL . Do.

88–318 ........................ Triprolidine Hydrochloride Tablets, 2.5 mg

Pseudoephedrine Hydrochloride Tablets, 60 mg.

Circa Pharmaceuticals.

88–332 ........................ Thioridazine Hydrochloride Tablets, 10 mg ........................ Mylan Pharmaceuticals, Inc.

88–333 ........................ Thioridazine Hydrochloride Tablets, 25 mg ........................ Do.

88–334 ........................ Thioridazine Hydrochloride Tablets, 50 mg ........................ Do.

88–335 ........................ Thioridazine Hydrochloride Tablets, 100 mg ...................... Do.

88–582 ........................ Quinidine Gluconate Sustained Release Tablets, 324 mg . Ascot Hospital Pharmaceuticals, Inc.

88–646 ........................ Methocarbamol Tablets, 500 mg ......................................... Roxane Laboratories, Inc.

89–079 ........................ Nitroglycerin Controlled Release Capsules, 9 mg .............. Ascot Hospital Pharmaceuticals, Inc.

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 ANDA’s listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective on May 26, 1995.

Dated: April 10, 1995.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 95–10272 Filed 4–25–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Advisory Commission on Childhood

Vaccines; Request for Nominations for

Voting Members

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

requesting nominations to fill three

vacancies on the Advisory Commission

on Childhood Vaccines (ACCV). The

ACCV was established by title XXI of

the Public Health Service Act (the Act),

as enacted by Public Law (Pub. L.) 99–

660 and as subsequently amended, and

advises the Secretary of Health and

Human Services (the Secretary) on

issues related to implementation of the

National Vaccine Injury Compensation

Program (VICP).

FOR FURTHER INFORMATION CONTACT: Mr.

Jerry Anderson, Principal Staff Liaison,

Policy and Commission Branch,

Division of Vaccine Injury

Compensation, at (301) 443–1533.

DATES: Nominations are to be submitted

by May 26, 1995.

ADDRESSES: All nominations are to be

submitted to the Director, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, HRSA, Parklawn

Building, Room 8A–35, 5600 Fishers

Lane, Rockville, Maryland 20857.

SUPPLEMENTARY INFORMATION: Under the

authorities that established the ACCV,

viz., the Federal Advisory Committee

Act of October 6, 1972 (P.L. 92–463) and

section 2119 of the Act, 42 U.S.C.

300aa–19, as added by P.L. 99–660 and

amended, HRSA is requesting

nominations for three voting members

of the ACCV.

The ACCV advises the Secretary on

the implementation of the VICP; on its

own initiative or as the result of the

filing of a petition, recommends changes

in the Vaccine Injury Table; advises the

Secretary in implementing the

Secretary’s responsibilities under

section 2127 regarding the need for

childhood vaccination products that

result in fewer or no significant adverse

reactions; surveys Federal, State, and

local programs and activities relating to

the gathering of information on injuries

associated with the administration of

childhood vaccines, including the

adverse reaction reporting requirements

of section 2125(b); advises the Secretary

on means to obtain, compile, publish,

and use credible data related to the

frequency and severity of adverse

reactions associated with childhood

vaccines; and recommends to the

Director, National Vaccine Program,

Office of the Assistant Secretary for

Health, research related to vaccine

injuries which should be conducted to

carry out the VICP.

The ACCV consists of nine members

appointed by the Secretary as follows:

Three health professionals, of whom at

least two are pediatricians, who are not

employees of the United States, who

have expertise in the health care of

children, the epidemiology, etiology and

prevention of childhood diseases, and

the adverse reactions associated with

vaccines; three members from the

general public, of whom at least two are

legal representatives of children who

have suffered a vaccine-related injury or

death; and three attorneys, of whom at

least one shall be an attorney whose

specialty includes representation of

persons who have suffered a vaccinerelated injury or death and one shall be

an attorney whose specialty includes

representation of vaccine

manufacturers. In addition, the Director

of the National Institutes of Health, the

Assistant Secretary for Health, the

Director of the Centers for Disease

Control and Prevention, and the

Commissioner of the Food and Drug

Administration (or the designees of such

officials) serve as nonvoting ex officio

members.

Specifically, HRSA is requesting

nominations for three voting members

of the ACCV representing: (1) A health

professional with special experience in

childhood diseases; (2) a member from

the general public who is a legal

representative of a child who has

suffered a vaccine-related injury or

death; and (3) an attorney whose

specialty includes representation of

persons who have suffered a vaccinerelated injury or death. Nominees will

be invited to serve 3-year terms

beginning January 1, 1996, and ending

December 31, 1998.

Interested persons may nominate one

or more qualified persons for