77 FR 115 pgs. 35691-35698 - Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications
Type: NOTICEVolume: 77Number: 115Pages: 35691 - 35698
Docket number: [Docket No. FDA-2012-N-0517]
FR document: [FR Doc. 2012-14476 Filed 6-13-12; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0517]
Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
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The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since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 Each of these applications will be deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES ).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 FDA's regulations provide that the Agency will consider withdrawn any application for which the applicant has not contacted the Agency about its intention regarding such application within 1 year after issuance of a complete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.
| ANDA No. | Product name |
|---|---|
| 60881 | Tetracycline hydrochloride. |
| 60913 | Dicloxacillin sodium. |
| 60919 | Neomycin sulfate; bacitracin. |
| 60965 | Neomycin sulfate; polymyxin b sulfates; bacitracin. |
| 61046 | Penicillin g sodium. |
| 61091 | Phenethicillin potassium. |
| 61093 | Penicillin g potassium. |
| 61097 | Troleandomycin. |
| 61099 | Doxycycline hyclate. |
| 61102 | Oxytetracycline calcium. |
| 61114 | Chlortetracycline hydrochloride. |
| 61116 | Ampicillin trihydrate. |
| 61117 | Phenethicillin potassium. |
| 61118 | Cloxacillin sodium. |
| 61119 | Dicloxacillin sodium. |
| 61120 | Tetracycline. |
| 61121 | Tetracycline phosphate. |
| 61142 | Penicillin g potassium. |
| 61144 | Amphotericin b. |
| 61145 | Penicillin g potassium. |
| 61152 | Tetracycline hydrochloride. |
| 61170 | Bacitracin. |
| 61171 | Bacitracin zinc. |
| 61191 | Tetracycline hydrochloride. |
| 61192 | Tetracycline hydrochloride. |
| 61194 | Paromomycin sulfate. |
| 61197 | Tetracycline hydrochloride. |
| 61382 | Ampicillin trihydrate. |
| 61420 | Tetracycline. |
| 61422 | Oxytetracycline hydrochloride. |
| 61423 | Oxytetracycline. |
| 61428 | Chloramphenicol palmitate. |
| 61429 | Tetracycline. |
| 61430 | Chloramphenicol. |
| 61431 | Chloramphenicol. |
| 61432 | Chloramphenicol sodium succinate. |
| 61433 | Chloramphenicol sodium succinate. |
| 61440 | Tetracycline hydrochloride. |
| 61442 | Erythromycin estolate. |
| 61556 | Tetracycline. |
| 61564 | Methacycline hydrochloride. |
| 61565 | Paromomycin sulfate. |
| 61570 | Hetacillin. |
| 61581 | Tetracycline hydrochloride. |
| 61582 | Tetracycline. |
| 61597 | Ampicillin trihydrate. |
| 61604 | Ampicillin sodium. |
| 61608 | Tetracycline hydrochloride. |
| 61629 | Penicillin g benzathine. |
| 61630 | Streptomycin sulfate. |
| 61631 | Dihydrostreptomycin sulfate. |
| 61749 | Dicloxacillin sodium. |
| 61750 | Ampicillin trihydrate. |
| 61751 | Doxycycline hyclate. |
| 61754 | Griseofulvin. |
| 61775 | Tetracycline. |
| 61777 | Mitomycin. |
| 61778 | Erythromycin. |
| 61779 | Erythromycin stearate. |
| 61784 | Tetracycline hydrochloride. |
| 61795 | Oxacillin sodium. |
| 61796 | Oxacillin sodium. |
| 61797 | Methicillin sodium. |
| 61804 | Carbenicillin indanyl sodium. |
| 61824 | Tetracycline. |
| 61825 | Tetracycline. |
| 61843 | Penicillin v potassium. |
| 61844 | Ampicillin. |
| 61845 | Ampicillin trihydrate. |
| 61852 | Tetracycline phosphate complex. |
| 61993 | Cloxacillin sodium. |
| 62016 | Amoxicillin trihydrate. |
| 62019 | Tetracycline hydrochloride. |
| 62020 | Tetracycline phosphate. |
| 62344 | Cloxacillin sodium. |
| 80004 | Propylthiouracil. |
| 80088 | Sulfadiazine. |
| 80200 | Succinylcholine chloride. |
| 80313 | Methyltestosterone. |
| 80350 | Prednisone. |
| 80351 | Prednisolone. |
| 80359 | Prednisone. |
| 80452 | Hydrocortisone. |
| 80456 | Hydrocortisone. |
| 80501 | Diphenhydramine hydrochloride. |
| 80559 | Cyanocobalamin. |
| 80560 | Pyridoxine hydrochloride. |
| 80561 | Thiamine hydrochloride. |
| 80616 | Cyanocobalamin. |
| 80676 | Testosterone propionate. |
| 80840 | Propylthiouracil. |
| 80943 | Vitamin a palmitate. |
| 80947 | Aminosalicylate sodium. |
| 80956 | Vitamin d. |
| 80985 | Vitamin a. |
| 83002 | Diethylstilbestrol. |
| 83003 | Diethylstilbestrol. |
| 83004 | Diethylstilbestrol. |
| 83005 | Diethylstilbestrol. |
| 83006 | Diethylstilbestrol. |
| 83007 | Diethylstilbestrol. |
| 83114 | Vitamin a palmitate. |
| 83133 | Folic acid. |
| 83134 | Vitamin a. |
| 83197 | Propoxyphene hydrochloride. |
| 83203 | Niacin. |
| 83208 | Cortisone acetate. |
| 83233 | Hydrocortisone acetate. |
| 83243 | Chlorpheniramine maleate. |
| 83258 | Butabarbital sodium. |
| 83259 | Pentobarbital sodium. |
| 83268 | Butabarbital sodium. |
| 83269 | Butabarbital sodium. |
| 83293 | Propoxyphene hydrochloride. |
| 83311 | Vitamin a palmitate. |
| 83321 | Vitamin a palmitate. |
| 83335 | Prednisolone acetate. |
| 83343 | Meprobamate. |
| 83374 | Estrogens, esterified. |
| 83394 | Chlorpheniramine maleate. |
| 83421 | Probenecid. |
| 83439 | Quinidine sulfate. |
| 83444 | Rauwolfia serpentina. |
| 83454 | Lidocaine. |
| 83494 | Meprobamate. |
| 83503 | Negatol. |
| 83537 | Secobarbital sodium. |
| 83553 | Procainamide hydrochloride. |
| 83562 | Prednisolone acetate. |
| 83578 | Butabarbital sodium. |
| 83674 | Diphenhydramine hydrochloride. |
| 83675 | Prednisolone. |
| 83676 | Prednisone. |
| 83756 | Piperazine citrate. |
| 83772 | Pyridoxine hydrochloride. |
| 83864 | Secobarbital sodium. |
| 83865 | Promethazine hydrochloride. |
| 83867 | Rauwolfia serpentina. |
| 83880 | Propoxyphene hydrochloride. |
| 83912 | Vitamin a palmitate. |
| 83926 | Ergotamine tartrate; caffeine. |
| 83929 | Cortisone acetate. |
| 83940 | Diethylstilbestrol. |
| 83958 | Propylthiouracil. |
| 83960 | Prednisolone. |
| 83974 | Trihexyphenidyl hydrochloride. |
| 84008 | Chlorpheniramine maleate. |
| 84009 | Prednisone. |
| 84016 | Dextroamphetamine hydrochloride. |
| 84027 | Promethazine hydrochloride. |
| 84073 | Benzthiazide. |
| 84080 | Promethazine hydrochloride. |
| 84097 | Dicyclomine hydrochloride. |
| 84237 | Niacin. |
| 84257 | Dicyclomine hydrochloride. |
| 84262 | Phenylbutazone. |
| 84263 | Dimenhydrinate. |
| 84293 | Dicyclomine hydrochloride. |
| 84298 | Hydrochlorothiazide. |
| 84311 | Phenylbutazone. |
| 84365 | Dexamethasone sodium phosphate. |
| 84382 | Meclizine hydrochloride. |
| 84410 | Trichlormethiazide. |
| 84428 | Propantheline bromide. |
| 84459 | Propylthiouracil. |
| 84485 | Phentermine hydrochloride. |
| 84552 | Aminophylline. |
| 84559 | Theophylline. |
| 84632 | Aminophylline. |
| 84670 | Chlordiazepoxide. |
| 84671 | Chlordiazepoxide. |
| 84672 | Chlordiazepoxide. |
| 84695 | Phentermine hydrochloride. |
| 84736 | Rescinnamine. |
| 84846 | Methocarbamol. |
| 84856 | Cortisone acetate. |
| 84871 | Prednisolone acetate. |
| 84906 | Reserpine; hydrochlorothiazide. |
| 84979 | Hydrocortisone. |
| 85033 | Methocarbamol. |
| 85115 | Prednisone. |
| 85170 | Prednisolone. |
| 85174 | Cortisone acetate. |
| 85185 | Diethylpropion hydrochloride. |
| 85207 | Reserpine. |
| 85242 | Chlordiazepoxide hydrochloride. |
| 85258 | Chlordiazepoxide. |
| 85259 | Chlordiazepoxide. |
| 85270 | Methyltestosterone. |
| 85280 | Chlordiazepoxide hydrochloride. |
| 85281 | Chlordiazepoxide hydrochloride. |
| 85308 | Phenytoin sodium. |
| 85325 | Methylprednisolone. |
| 85360 | Chlordiazepoxide hydrochloride. |
| 85405 | Perphenazine. |
| 85412 | Tripelennamine hydrochloride. |
| 85419 | Quinidine sulfate. |
| 85439 | Butalbital; aspirin; phenacetin; caffeine. |
| 85442 | Chlordiazepoxide hydrochloride. |
| 85489 | Probenecid. |
| 85516 | Theophylline. |
| 85576 | Estradiol. |
| 85590 | Oxyphenbutazone. |
| 85592 | Brompheniramine maleate. |
| 85613 | Phendimetrazine tartrate. |
| 85647 | Amitriptyline hydrochloride. |
| 85649 | Amitriptyline hydrochloride. |
| 85678 | Amitriptyline hydrochloride. |
| 85680 | Amitriptyline hydrochloride. |
| 85696 | Isoniazid; pyridoxine hydrochloride. |
| 85707 | Isopropamide iodide. |
| 85716 | Hydralazine hydrochloride. |
| 85717 | Hydralazine hydrochloride. |
| 85725 | Phendimetrazine tartrate. |
| 85730 | Cyanocobalamin. |
| 85731 | Phentermine hydrochloride. |
| 85760 | Chlorothiazide. |
| 85774 | Methyltestosterone. |
| 85776 | Methyltestosterone. |
| 85806 | Reserpine; hydralazine hydrochloride; hydrochlorotiazide. |
| 85807 | Meclizine hydrochloride. |
| 85808 | Meclizine hydrochloride. |
| 85812 | Propoxyphene hydrochloride. |
| 85901 | Imipramine hydrochloride. |
| 85918 | Ergotamine tartrate; caffeine. |
| 85942 | Amitriptyline hydrochloride. |
| 85943 | Triamcinolone acetonide. |
| 85946 | Amitriptyline hydrochloride. |
| 85947 | Amitriptyline hydrochloride. |
| 85948 | Amitriptyline hydrochloride. |
| 85949 | Amitriptyline hydrochloride. |
| 85950 | Amitriptyline hydrochloride. |
| 85954 | Methyltestosterone. |
| 85955 | Methyltestosterone. |
| 85972 | Acetaminophen; salicylamide; caffeine; codeine phosphate. |
| 86068 | Triamcinolone acetonide. |
| 86111 | Amodiaquine hydrochloride. |
| 86115 | Bethanechol chloride. |
| 86125 | Quinidine sulfate. |
| 86128 | Chlorpromazine. |
| 86131 | Acetazolamide. |
| 86207 | Hydrocortisone acetate. |
| 86211 | Phendimetrazine tartrate. |
| 86253 | Trihexyphenidyl hydrochloride. |
| 86254 | Chlorothiazide. |
| 86279 | Hydrochlorothiazide. |
| 86286 | Butalbital; aspirin; phenacetin; caffeine. |
| 86288 | Amitriptyline hydrochloride. |
| 86316 | Orphenadrine citrate. |
| 86317 | Diphenoxylate hydrochloride; atropine sulfate. |
| 86318 | Hydrochlorothiazide. |
| 86319 | Hydrochlorothiazide. |
| 86320 | Methocarbamol. |
| 86321 | Methocarbamol. |
| 86322 | Prednisone. |
| 86324 | Prednisone. |
| 86326 | Butalbital; aspirin; phenacetin; caffeine. |
| 86327 | Trifluoperazine hydrochloride. |
| 86334 | Hydrocortisone. |
| 86343 | Thioridazine hydrochloride. |
| 86345 | Thioridazine hydrochloride. |
| 86354 | Thioridazine hydrochloride. |
| 86377 | Hydrochlorothiazide. |
| 86400 | Hydrocortisone acetate. |
| 86401 | Hydrocortisone acetate. |
| 86404 | Phendimetrazine tartrate. |
| 86407 | Phendimetrazine tartrate. |
| 86411 | Dimenhydrinate. |
| 86412 | Dicyclomine hydrochloride. |
| 86430 | Phendimetrazine;adipic acid. |
| 86431 | Phendimetrazine. |
| 86436 | Homatropine methylbromide. |
| 86437 | Homatropine hydrobromide. |
| 86438 | Trifluoperazine hydrochloride. |
| 86443 | Trifluoperazine hydrochloride. |
| 86447 | Trifluoperazine hydrochloride. |
| 86476 | Diazepam. |
| 86510 | Phentermine hydrochloride. |
| 86515 | Phentermine hydrochloride. |
| 86529 | Dicyclomine hydrochloride; phenobarbital. |
| 86555 | Phendimetrazine tartrate. |
| 86563 | Dicyclomine hydrochloride; phenobarbital. |
| 86564 | Phenobarbital; atropine sulfate; hyoscyamine sulfate; hyscyamine hydrobromide. |
| 86565 | Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. |
| 86566 | Dicyclomine hydrochloride; phenobarbital. |
| 86581 | Chlordiazepoxide hydrochloride; clidinium bromide. |
| 86591 | Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. |
| 86625 | Dicyclomine hydrochloride. |
| 86627 | Meprobamate; tridihexethyl chloride. |
| 86629 | Meprobamate; tridihexethyl chloride. |
| 86630 | Piperidolate hydrochloride; phenobarbital. |
| 86634 | Chlordiazepoxide hydrochloride; clidinium bromide. |
| 86644 | Piperidolate hydrochloride. |
| 86647 | Chlordiazepoxide hydrochloride; clidinium bromide. |
| 86650 | Anisotropine methylbromide; phenobarbital. |
| 86654 | Meprobamate; tridihexethyl chloride. |
| 86655 | Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide. |
| 86657 | Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide. |
| 86658 | Meprobamate; tridihexethyl chloride. |
| 86665 | Phenobarbital; atropine sulfate; hyoscyamine sulfate; scopolamine hydrobromide. |
| 86667 | Chlordiazepoxide hydrochloride; clidinium bromide. |
| 86668 | Phenobarbital; belladonna alkaloid malates, l-. |
| 86669 | Dicyclomine hydrochloride. |
| 86670 | Atropine sulfate; hyoscyamine sulfate; phenobarbital; scopolamine hydrobromide. |
| 86671 | Phenobarbital; hyoscyamine sulfate. |
| 86674 | Meprobamate; tridihexethyl chloride. |
| 86675 | Butabarbital sodium; simethicone; atropine sulfate; hyoscyamine sulfate; scopoamine. |
| 86685 | Chlordiazepoxide hydrochloride; clidinium bromide. |
| 86687 | Phenobarbital; belladonna extract. |
| 86692 | Amobarbital; belladonna. |
| 86694 | Oxyphencyclimine hydrochloride; phenobarbital. |
| 86696 | Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. |
| 86701 | Atropine sulfate; phenobarbital. |
| 86703 | Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. |
| 86704 | Phenobarbital; hyoscyamine sulfate; atropine sulfate; scopolamine hydrobromide. |
| 86706 | Meprobamate; tridihexethyl chloride. |
| 86708 | Cyproheptadine hydrochloride. |
| 86709 | Meprobamate; tridihexethyl chloride. |
| 86721 | Procainamide hydrochloride. |
| 86770 | Nitroglycerin. |
| 86773 | Triamcinolone diacetate. |
| 86774 | Erythrityl tetranitrate. |
| 86775 | Isosorbide dinitrate. |
| 86776 | Pentaerythritol tetranitrate. |
| 86777 | Nitroglycerin. |
| 86779 | Nitroglycerin. |
| 86782 | Nitroglycerin. |
| 86783 | Isosorbide dinitrate. |
| 86784 | Pentaerythritol tetranitrate. |
| 86785 | Pentaerythritol tetranitrate. |
| 86786 | Isosorbide dinitrate. |
| 86789 | Estradiol valerate. |
| 86794 | Dipyridamole. |
| 86799 | Atropine sulfate; phenobarbital. |
| 86838 | Pentaerythritol tetranitrate. |
| 86839 | Isosorbide dinitrate. |
| 86868 | Chlorpromazine hydrochloride. |
| 86882 | Hydrocortisone. |
| 86897 | Phenobarbital; hyoscyamine hydrobromide; atropine sulfate; scopolamine hydrobromide. |
| 86921 | Chlordiazepoxide hydrochloride; clidinum bromide. |
| 86970 | Aminophylline. |
| 86976 | Doxylamine succinate; pyridoxine hydrochloride. |
| 86991 | Probenecid. |
| 86999 | Butalbital; aspirin; phenacetin; caffeine. |
| 87000 | Hydralazine hydrochloride. |
| 87041 | Phendimetrazine tartrate. |
| 87064 | Piperazine citrate. |
| 87069 | Sulfisoxazole acetyl. |
| 87096 | Phentermine hydrochloride. |
| 87097 | Phentermine hydrochloride. |
| 87098 | Phentermine hydrochloride. |
| 87099 | Phentermine hydrochloride. |
| 87106 | Ergotamine tartrate; caffeine. |
| 87112 | Spironolactone. |
| 87116 | Reserpine; chlorothiazide. |
| 87123 | Benzthiazide. |
| 87124 | Benzthiazide. |
| 87125 | Diphenhydramine hydrochloride. |
| 87134 | Promethazine hydrochloride. |
| 87166 | Phentolamine hydrochloride. |
| 87172 | Theophylline. |
| 87198 | Belladonna alkaloid malates, l-; phenobarbital. |
| 87379 | Quinidine gluconate. |
| 87443 | Homatropine 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