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Notice

Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications

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ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES).

DATES:

The applicant of an ANDA covered by this notice that intends to actively pursue approval of its application must submit a written notification to FDA by August 13, 2012.

ADDRESSES:

Applicants should submit written notifications to the ANDA archival file to the Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, MPN7, 7620 Standish Pl., Rockville, MD 20855. A copy of written notifications should also be submitted to Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD-617), Food and Drug Administration, 7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, FAX: 240-276-8440, email: inactiveandas@fda.hhs.gov.

FOR FURTHER INFORMATION CONTACT:

Thomas Hinchliffe, Center for Drug Evaluation and Research (HFD-617), Food and Drug Administration, 7500 Standish Pl., rm. N-142, MPN2, Rockville, MD 20855, 240-276-8433, FAX: 240-276-9310, email: inactiveandas@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

FDA has identified 364 ANDAs for which FDA has not received any communication from the ANDA applicant since July 8, 1991, or earlier (Inactive ANDAs). (See section IV of this document for the list of Inactive ANDAs). For purposes of this document, the term “applicant” includes any successor in interest. FDA's regulations provide that the Agency will consider withdrawn any application for which the applicant has not contacted the Agency about its intention regarding such application within 1 year after issuance of a complete response letter to the applicant (see 21 CFR 314.110(c)). The Inactive ANDAs, however, predate, and consequently are not subject to this regulation. Therefore, the Inactive ANDAs have not been deemed withdrawn although there has been no communication from the applicants since July 8, 1991, or earlier.

II. Withdrawal of Inactive ANDAs

At this time, the Agency is announcing its intention to deem all Inactive ANDAs to have been voluntarily withdrawn by the respective applicants as of August 13, 2012, unless the applicant informs the Agency in writing by the date set forth under DATES in this document of its intent to actively pursue approval of the application. Therefore, in the absence of a written notice with respect to an Inactive ANDA by the date specified in this notice, the ANDA will be considered to have been withdrawn by the applicant. No further notice of the withdrawal of Inactive ANDAs will be provided. Withdrawal of an unapproved application is without prejudice to resubmission of that application (21 CFR 314.65). Because of the length of time that has passed since these applications were submitted, FDA strongly recommends that any applicant intending to actively pursue approval review the application carefully to determine whether it satisfies current ANDA requirements (21 CFR part 314).

III. Action by the Applicant

If the applicant wishes to actively pursue approval of an Inactive ANDA and does not wish the application to be deemed by FDA to have been voluntarily withdrawn, the applicant must inform the Agency in writing within the time specified in this document. Written notice should be provided to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES).

FDA also asks any applicant that agrees to consider its application to be voluntarily withdrawn to send a written notice to Thomas Hinchliffe and the Office of Generic Drugs (see ADDRESSES) to confirm that agreement. However, applicants of Inactive ANDAs covered by this notice who wish their applications to be withdrawn are not required to provide written notice to FDA.

IV. Details About Inactive ANDAs

Information about the Inactive ANDAs is listed in this section of the document. To protect applicant confidentiality, this notice lists the application number and drug name for each Inactive ANDA and separately lists the name of the applicant as shown in the information on file with FDA, without linking identified applicants with specific applications or drug names. In some cases, the identified applicants may no longer exist as ongoing business entities. If an identified applicant is unsure which application(s) belong to it (if any), it may contact Thomas Hinchliffe (see FOR FURTHER INFORMATION CONTACT).

Alphabetical List of Abbreviated New Drug Application Applicants

1st Texas Pharmaceuticals, Inc., Subsidiary of Scherer Laboratories Inc.

Abraxis Pharmaceutical Products

AH Robins, Co.

Alpharma US Pharmaceuticals Division

Ambix Laboratories Division of Organics Corp America

Ankerfarm SpA

Ankerman SpA

Antibioticos SA

Arcum Pharmaceutical Corp.

Banner Pharmacaps, Inc.

Barr Laboratories, Inc.

Baxter Healthcare Corp.

Beecham Laboratories Division of Beecham Inc.

Beecham SA

Bel Mar Laboratories, Inc.

Biocraft Laboratories, Inc.

Biometric Testing, Inc.

Boots Laboratories, Inc., Division of Boots Pharmaceuticals Inc.

Bristol Laboratories, Inc., Division of Bristol Myers Co.

Bristol Myers Co. International Division

Bristol Myers Industrial Division

Bristol Myers Squibb

Camall Co., Inc.

Carlo Erba SpA

Century Pharmaceuticals, Inc.

Chemibiotic Ireland, Ltd.

Chromalloy Laboratories Division of Chromalloy Pharmaceuticals, Inc.

Clifford Chemical Corp.

CM Bundy Co.

Comatic Laboratories, Inc.

Credo Co.

Delco Chemical Co., Inc.

Dell Laboratories, Inc.

Dermasave Laboratories, Inc.

Dista Products Co. Division of Eli Lilly & Co.

DM Pharmaceuticals, Inc.

Dorasol Laboratories

Dunhall Pharmaceuticals, Inc.

ER Squibb and Sons Pharmaceutical Laboratories

Ersana, Inc., Subsidiary of ER Squibb and Sons

Everylife

Fallek Products Co., Inc.

Farmila Farmaceutica

Faton Pharmaceuticals, Inc.

Fermion Oy

Ferndale Laboratories, Inc.

Fisons Corp.

Forest Laboratories, Inc.

Forest Pharmaceuticals, Inc.

Forrest Laboratories, Inc.

G & W Co.

Glenwood Laboratories, Inc.

Global Pharmaceutical Corp.

Gruppo Lepetit SpA Subsidiary of Merrell Dow Pharmaceuticals, Inc.

Heather Drug Co., Inc.

Herald Pharmacal, Inc.

Hoffmann La Roche, Inc.

ICI Ltd.

Ingram Pharmaceutical Co.

Inwood Laboratories, Inc., Subsidiary of Forest Laboratories, Inc.

ISF

Kasar Laboratories Division of Kasar Co.

Kasco EFCO Laboratories, Inc., Division of Byk Gulden, Inc.

KV Pharmaceutical, Co.

Lannett Co, Inc.

Lederle Laboratories Division of American Cyanamid Co.

Leiner Health Products, Inc.

Lemmon Co. Subsidiary of Tag Pharmaceutical, Inc.

Life Laboratories, Inc.

Linden Laboratories, Inc., Subsidiary of Chromalloy American Corp.

Luitpold Pharmaceuticals, Inc.

Marshall Pharmacal Corp.

MD Pharmaceutical, Inc.

Medev, Inc.

Mission Pharmacal Co.

M M Mast & Co.

Mutual Pharmaceutical Company, Inc.

Newtron Pharmaceuticals, Inc.

Novartis Pharmaceuticals Corp.

Nylos Trading Co., Inc.

Panray Corp Subsidiary of Ormont Drug and Chemical Co., Inc.

Parke Davis Division of Warner Lambert Co.

Pasadena Research Laboratories, Inc.

Penick Corp.

Person and Covey, Inc.

Pfizer Co.

Pfizer, Inc.

Pharmaceutical Associates, Inc.

Pharmacia and Upjohn Co.

Pharmadyne Laboratories, Inc.

Pharmavite Pharmaceuticals

Phoenix Laboratories, Inc.

Polfa Pharmaceutical Works

Premo Pharmaceutical Laboratories, Inc.

Purepac Pharmaceutical Co.

Rachelle Laboratories Italia SpA

Reed and Carnrick Division of Block Drug Co., Inc.

Rexar Pharmacal

Richlyn Laboratories, Inc.

Robinson Laboratories, Inc.

Roussel Corp.

Rovers Pharmacal, Inc.

RP Scherer Corp.

Sandoz, Inc.

Scherer Laboratories, Inc.

Schering Corp. Subsidiary of Schering Plough Corp.

Smith Kline and French Laboratory Co. Subsidiary of SmithKline Beckman

Societa Italiana Prodotti Schering

Sperti Drug Products, Inc.

Stayner Corp.

Steri Med, Inc. Subsidiary of Ketchum Laboratories, Inc.

Tablicaps, Inc.

Tera Pharmaceuticals, Inc.

Teva Pharmaceuticals USA, Inc.

Titan Pharmacal, Co.

Travenol Laboratories, Inc.

Valeant Pharmaceuticals International

Watson Laboratories, Inc.

Western Research Laboratories, Inc.

West-Ward Pharmaceutical Corp.

Wharton Laboratories, Inc., Division of US Ethicals

Whiteworth Towne Paulsen, Inc.

Wyeth Ayerst Laboratories

Zenith Laboratories, Inc.

Table 1—Abbreviated New Drug Application (ANDA) Numbers With Product Names

ANDA No.Product name
60881Tetracycline hydrochloride.
60913Dicloxacillin sodium.
60919Neomycin sulfate; bacitracin.
60965Neomycin sulfate; polymyxin b sulfates; bacitracin.
61046Penicillin g sodium.
61091Phenethicillin potassium.
61093Penicillin g potassium.
61097Troleandomycin.
61099Doxycycline hyclate.
61102Oxytetracycline calcium.
61114Chlortetracycline hydrochloride.
61116Ampicillin trihydrate.
61117Phenethicillin potassium.
61118Cloxacillin sodium.
61119Dicloxacillin sodium.
61120Tetracycline.
61121Tetracycline phosphate.
61142Penicillin g potassium.
61144Amphotericin b.
61145Penicillin g potassium.
61152Tetracycline hydrochloride.
61170Bacitracin.
61171Bacitracin zinc.
61191Tetracycline hydrochloride.
61192Tetracycline hydrochloride.
61194Paromomycin sulfate.
61197Tetracycline hydrochloride.
61382Ampicillin trihydrate.
61420Tetracycline.
61422Oxytetracycline hydrochloride.
61423Oxytetracycline.
61428Chloramphenicol palmitate.
61429Tetracycline.
61430Chloramphenicol.
61431Chloramphenicol.
61432Chloramphenicol sodium succinate.
61433Chloramphenicol sodium succinate.
61440Tetracycline hydrochloride.
61442Erythromycin estolate.
61556Tetracycline.
61564Methacycline hydrochloride.
61565Paromomycin sulfate.
61570Hetacillin.
61581Tetracycline hydrochloride.
61582Tetracycline.
61597Ampicillin trihydrate.
61604Ampicillin sodium.
61608Tetracycline hydrochloride.
61629Penicillin g benzathine.
61630Streptomycin sulfate.
61631Dihydrostreptomycin sulfate.
61749Dicloxacillin sodium.
61750Ampicillin trihydrate.
61751Doxycycline hyclate.
61754Griseofulvin.
61775Tetracycline.
61777Mitomycin.
61778Erythromycin.
61779Erythromycin stearate.
61784Tetracycline hydrochloride.
61795Oxacillin sodium.
61796Oxacillin sodium.
61797Methicillin sodium.
61804Carbenicillin indanyl sodium.
61824Tetracycline.
61825Tetracycline.
61843Penicillin v potassium.
61844Ampicillin.
61845Ampicillin trihydrate.
61852Tetracycline phosphate complex.
61993Cloxacillin sodium.
62016Amoxicillin trihydrate.
62019Tetracycline hydrochloride.
62020Tetracycline phosphate.
62344Cloxacillin sodium.
80004Propylthiouracil.
80088Sulfadiazine.
80200Succinylcholine chloride.
80313Methyltestosterone.
80350Prednisone.
80351Prednisolone.
80359Prednisone.
80452Hydrocortisone.
80456Hydrocortisone.
80501Diphenhydramine hydrochloride.
80559Cyanocobalamin.
80560Pyridoxine hydrochloride.
80561Thiamine hydrochloride.
80616Cyanocobalamin.
80676Testosterone propionate.
80840Propylthiouracil.
80943Vitamin a palmitate.
80947Aminosalicylate sodium.
80956Vitamin d.
80985Vitamin a.
83002Diethylstilbestrol.
83003Diethylstilbestrol.
83004Diethylstilbestrol.
83005Diethylstilbestrol.
83006Diethylstilbestrol.
83007Diethylstilbestrol.
83114Vitamin a palmitate.
83133Folic acid.
83134Vitamin a.
83197Propoxyphene hydrochloride.
83203Niacin.
83208Cortisone acetate.
83233Hydrocortisone acetate.
83243Chlorpheniramine maleate.
83258Butabarbital sodium.
83259Pentobarbital sodium.
83268Butabarbital sodium.
83269Butabarbital sodium.
83293Propoxyphene hydrochloride.
83311Vitamin a palmitate.
83321Vitamin a palmitate.
83335Prednisolone acetate.
83343Meprobamate.
83374Estrogens, esterified.
83394Chlorpheniramine maleate.
83421Probenecid.
83439Quinidine sulfate.
83444Rauwolfia serpentina.
83454Lidocaine.
83494Meprobamate.
83503Negatol.
83537Secobarbital sodium.
83553Procainamide hydrochloride.
83562Prednisolone acetate.
83578Butabarbital sodium.
83674Diphenhydramine hydrochloride.
83675Prednisolone.
83676Prednisone.
83756Piperazine citrate.
83772Pyridoxine hydrochloride.
83864Secobarbital sodium.
83865Promethazine hydrochloride.
83867Rauwolfia serpentina.
83880Propoxyphene hydrochloride.
83912Vitamin a palmitate.
83926Ergotamine tartrate; caffeine.
83929Cortisone acetate.
83940Diethylstilbestrol.
83958Propylthiouracil.
83960Prednisolone.
83974Trihexyphenidyl hydrochloride.
84008Chlorpheniramine maleate.
84009Prednisone.
84016Dextroamphetamine hydrochloride.
84027Promethazine hydrochloride.
84073Benzthiazide.
84080Promethazine hydrochloride.
84097Dicyclomine hydrochloride.
84237Niacin.
84257Dicyclomine hydrochloride.
84262Phenylbutazone.
84263Dimenhydrinate.
84293Dicyclomine hydrochloride.
84298Hydrochlorothiazide.
84311Phenylbutazone.
84365Dexamethasone sodium phosphate.
84382Meclizine hydrochloride.
84410Trichlormethiazide.
84428Propantheline bromide.
84459Propylthiouracil.
84485Phentermine hydrochloride.
84552Aminophylline.
84559Theophylline.
84632Aminophylline.
84670Chlordiazepoxide.
84671Chlordiazepoxide.
84672Chlordiazepoxide.
84695Phentermine hydrochloride.
84736Rescinnamine.
84846Methocarbamol.
84856Cortisone acetate.
84871Prednisolone acetate.
84906Reserpine; hydrochlorothiazide.
84979Hydrocortisone.
85033Methocarbamol.
85115Prednisone.
85170Prednisolone.
85174Cortisone acetate.
85185Diethylpropion hydrochloride.
85207Reserpine.
85242Chlordiazepoxide hydrochloride.
85258Chlordiazepoxide.
85259Chlordiazepoxide.
85270Methyltestosterone.
85280Chlordiazepoxide hydrochloride.
85281Chlordiazepoxide hydrochloride.
85308Phenytoin sodium.
85325Methylprednisolone.
85360Chlordiazepoxide hydrochloride.
85405Perphenazine.
85412Tripelennamine hydrochloride.
85419Quinidine sulfate.
85439Butalbital; aspirin; phenacetin; caffeine.
85442Chlordiazepoxide hydrochloride.
85489Probenecid.
85516Theophylline.
85576Estradiol.
85590Oxyphenbutazone.
85592Brompheniramine maleate.
85613Phendimetrazine tartrate.
85647Amitriptyline hydrochloride.
85649Amitriptyline hydrochloride.
85678Amitriptyline hydrochloride.
85680Amitriptyline hydrochloride.
85696Isoniazid; pyridoxine hydrochloride.
85707Isopropamide iodide.
85716Hydralazine hydrochloride.
85717Hydralazine hydrochloride.
85725Phendimetrazine tartrate.
85730Cyanocobalamin.
85731Phentermine hydrochloride.
85760Chlorothiazide.
85774Methyltestosterone.
85776Methyltestosterone.
85806Reserpine; hydralazine hydrochloride; hydrochlorotiazide.
85807Meclizine hydrochloride.
85808Meclizine hydrochloride.
85812Propoxyphene hydrochloride.
85901Imipramine hydrochloride.
85918Ergotamine tartrate; caffeine.
85942Amitriptyline hydrochloride.
85943Triamcinolone acetonide.
85946Amitriptyline hydrochloride.
85947Amitriptyline hydrochloride.
85948Amitriptyline hydrochloride.
85949Amitriptyline hydrochloride.
85950Amitriptyline hydrochloride.
85954Methyltestosterone.
85955Methyltestosterone.
85972Acetaminophen; salicylamide; caffeine; codeine phosphate.
86068Triamcinolone acetonide.
86111Amodiaquine hydrochloride.
86115Bethanechol chloride.
86125Quinidine sulfate.
86128Chlorpromazine.
86131Acetazolamide.
86207Hydrocortisone acetate.
86211Phendimetrazine tartrate.
86253Trihexyphenidyl hydrochloride.
86254Chlorothiazide.
86279Hydrochlorothiazide.
86286Butalbital; aspirin; phenacetin; caffeine.
86288Amitriptyline hydrochloride.
86316Orphenadrine citrate.
86317Diphenoxylate hydrochloride; atropine sulfate.
86318Hydrochlorothiazide.
86319Hydrochlorothiazide.
86320Methocarbamol.
86321Methocarbamol.
86322Prednisone.
86324Prednisone.
86326Butalbital; aspirin; phenacetin; caffeine.
86327Trifluoperazine hydrochloride.
86334Hydrocortisone.
86343Thioridazine hydrochloride.
86345Thioridazine hydrochloride.
86354Thioridazine hydrochloride.
86377Hydrochlorothiazide.
86400Hydrocortisone acetate.
86401Hydrocortisone acetate.
86404Phendimetrazine tartrate.
86407Phendimetrazine tartrate.
86411Dimenhydrinate.
86412Dicyclomine hydrochloride.
86430Phendimetrazine;adipic acid.
86431Phendimetrazine.
86436Homatropine methylbromide.
86437Homatropine hydrobromide.
86438Trifluoperazine hydrochloride.
86443Trifluoperazine hydrochloride.
86447Trifluoperazine hydrochloride.
86476Diazepam.
86510Phentermine hydrochloride.
86515Phentermine hydrochloride.
86529Dicyclomine hydrochloride; phenobarbital.
86555Phendimetrazine tartrate.
86563Dicyclomine hydrochloride; phenobarbital.
86564Phenobarbital; atropine sulfate; hyoscyamine sulfate; hyscyamine hydrobromide.
86565Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide.
86566Dicyclomine hydrochloride; phenobarbital.
86581Chlordiazepoxide hydrochloride; clidinium bromide.
86591Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide.
86625Dicyclomine hydrochloride.
86627Meprobamate; tridihexethyl chloride.
86629Meprobamate; tridihexethyl chloride.
86630Piperidolate hydrochloride; phenobarbital.
86634Chlordiazepoxide hydrochloride; clidinium bromide.
86644Piperidolate hydrochloride.
86647Chlordiazepoxide hydrochloride; clidinium bromide.
86650Anisotropine methylbromide; phenobarbital.
86654Meprobamate; tridihexethyl chloride.
86655Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide.
86657Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide.
86658Meprobamate; tridihexethyl chloride.
86665Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide.
86667Chlordiazepoxide hydrochloride; clidinium bromide.
86668Phenobarbital; belladonna alkaloid malates, l-.
86669Dicyclomine hydrochloride.
86670Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide.
86671Phenobarbital; hyoscyamine sulfate.
86674Meprobamate; tridihexethyl chloride.
86675Butabarbital sodium; simethicone; atropine sulfate; hyoscyamine sulfate; scopoamine.
86685Chlordiazepoxide hydrochloride; clidinium bromide.
86687Phenobarbital; belladonna extract.
86692Amobarbital; belladonna.
86694Oxyphencyclimine hydrochloride; phenobarbital.
86696Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide.
86701Atropine sulfate; phenobarbital.
86703Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide.
86704Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide.
86706Meprobamate; tridihexethyl chloride.
86708Cyproheptadine hydrochloride.
86709Meprobamate; tridihexethyl chloride.
86721Procainamide hydrochloride.
86770Nitroglycerin.
86773Triamcinolone diacetate.
86774Erythrityl tetranitrate.
86775Isosorbide dinitrate.
86776Pentaerythritol tetranitrate.
86777Nitroglycerin.
86779Nitroglycerin.
86782Nitroglycerin.
86783Isosorbide dinitrate.
86784Pentaerythritol tetranitrate.
86785Pentaerythritol tetranitrate.
86786Isosorbide dinitrate.
86789Estradiol valerate.
86794Dipyridamole.
86799Atropine sulfate; phenobarbital.
86838Pentaerythritol tetranitrate.
86839Isosorbide dinitrate.
86868Chlorpromazine hydrochloride.
86882Hydrocortisone.
86897Phenobarbital; hyoscyamine hydrobromide; atropine sulfate; scopolamine hydrobromide.
86921Chlordiazepoxide hydrochloride; clidinum bromide.
86970Aminophylline.
86976Doxylamine succinate; pyridoxine hydrochloride.
86991Probenecid.
86999Butalbital; aspirin; phenacetin; caffeine.
87000Hydralazine hydrochloride.
87041Phendimetrazine tartrate.
87064Piperazine citrate.
87069Sulfisoxazole acetyl.
87096Phentermine hydrochloride.
87097Phentermine hydrochloride.
87098Phentermine hydrochloride.
87099Phentermine hydrochloride.
87106Ergotamine tartrate; caffeine.
87112Spironolactone.
87116Reserpine; chlorothiazide.
87123Benzthiazide.
87124Benzthiazide.
87125Diphenhydramine hydrochloride.
87134Promethazine hydrochloride.
87166Phentolamine hydrochloride.
87172Theophylline.
87198Belladonna alkaloid malates, l-; phenobarbital.
87379Quinidine gluconate.
87443Homatropine methylbromide; phenobarbital.

Dated: June 8, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2012-14476 Filed 6-13-12; 8:45 am]

BILLING CODE 4160-01-P