Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications, 10651-10657 [05-4158]
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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
growth between the smoking process
and distribution at retail, and (3)
recontamination with L. monocytogenes
during the manufacturing and/or
processing of smoked finfish.
Listeria monocytogenes
contamination is a problem in coldsmoked finfish because the heat applied
during processing is not sufficient to
inactivate the organism, and the fish are
consumed without further cooking.
Cold-smoked finfish may become
contaminated during processing due to
inadequate sanitation, particularly
because of insufficient cleaning and
sterilizing of the slicer. For hot-smoked
finfish, although L. monocytogenes is
killed by adequate hot-smoking,
recontamination after hot-smoking can
result in high numbers of the organism
in the finished products. Additionally,
the ability of the organism to grow
under both refrigerated aerobic and
anaerobic conditions makes it a concern
in products packed in permeable
wrappers and under modified
atmosphere or vacuum. This sealing of
the product extends shelf-life and,
therefore, provides additional time for
the organism to grow.
Preventive Controls for L.
monocytogenes in Retail and
Foodservice Establishments: FDA is
evaluating the Food Code to determine
whether it should consider
recommending revisions to the
provisions addressing preventive
controls for L. monocytogenes in retail
and foodservice establishments.
Specifically, FDA will take the
following steps: (1) Review the Food
Code to determine whether it should
consider recommending revisions to the
provisions that address preventive
controls, such as approved source, date
marking, and cold holding times and
temperatures; and (2) in conjunction
with the Conference for Food
Protection, issue guidance to the retail
and food service industries and State
and local regulatory professionals on the
use of Hazard Analysis Critical Control
Point (HACCP) principles to identify
and control risk factors contributing to
foodborne illness. FDA intends for such
guidance to discuss intervention
strategies that industry can use to
control L. monocytogenes and other
pathogens.
II. Request for Comments and for
Scientific Data and Information
Smoked Finfish Risk Assessment:
FDA requests comments on the risk
assessment approach outlined
previously in this document and the
submission of data and any information
relevant to this risk assessment. The
agency specifically requests information
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for the following: (1) L. monocytogenes
levels in raw fish, smoked fish, and
finished product; (2) effect of mitigation
measures (e.g., ozonation, acidified
sodium chlorite) to reduce L.
monocytogenes levels in raw and
finished product; (3) potential for
transfer of L. monocytogenes to food
from contaminated food contact and
noncontact surfaces during
manufacturing and/or processing (e.g.,
equipment, workers, floor drains, etc.);
(4) potential for transfer of L.
monocytogenes from the slicer to coldsmoked fish; (5) impact of adding
inhibitors (e.g., bacteriocins and
bacteriocins-producing bacterial strains
or sodium lactate) to smoked finfish to
reduce or prevent L. monocytogenes
growth; (6) impact of frozen versus
refrigerated storage conditions on levels
of L. monocytogenes; (7) impact of time
and temperature on levels of L.
monocytogenes for commercial and
home storage conditions of finished
product; and (8) effect of training
regarding sanitation and hygienic
practices on reducing the levels of L.
monocytogenes in smoked finfish.
Preventive Controls for L.
monocytogenes in Retail and
Foodservice Establishments: Under the
FDA/CDC Listeria Action Plan, FDA is
continuing its commitment to review
the Food Code to determine whether it
should consider recommending
revisions to the provisions that address
preventive controls for Listeria in retail
and foodservice establishments. The
agency specifically requests the
following data and information: (1) L.
monocytogenes levels in products stored
in retail and foodservice establishments;
(2) levels of environmental
contamination and harborage of L.
monocytogenes on food contact and
nonfood contact surfaces in retail and
foodservice establishments (e.g.,
equipment, workers, floor drains, etc.);
(3) effects of short- and long-term
refrigerated storage on levels of L.
monocytogenes in retail and foodservice
establishments; (4) impact of time and
temperature on levels of L.
monocytogenes in products stored in
retail and foodservice establishments;
(5) efficacy of cleaning procedures and
sanitizing agents on environmental
surfaces and utensils; (6) frequency of
use and impact of adding inhibitors to
food products in retail and foodservice
establishments to reduce or prevent L.
monocytogenes growth; and (7) effect of
training regarding hygienic practices
and sanitation on levels of L.
monocytogenes in products in retail and
foodservice establishments.
Interested persons should submit
comments, scientific data, and
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10651
information to the Division of Dockets
Management (see ADDRESSES). Three
copies of all comments, scientific data,
and information are to be submitted.
Individuals submitting written
information or anyone submitting
electronic comments may submit one
copy. Submissions are to be identified
with the docket number found in
brackets in the heading of this
document and may be accompanied by
supporting information. Received
submissions may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Information submitted after the closing
date will not be considered except by
petition under 21 CFR 10.30.
III. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. U.S. Department of Health and Human
Services, Healthy People 2010, v. 1.
Washington, DC, 2000, https://
www.healthypeople.gov.
2. U.S. Department of Health and Human
Services and U.S. Department of Agriculture/
Food Safety and Inspection Service,
‘‘Quantitative Assessment of Relative Risk to
Public Health from Foodborne Listeria
monocytogenes Among Selected Categories
of Ready-to-Eat Foods,’’ September 2003,
https://www.foodsafety.gov/~dms/lmr2–
toc.html.
3. U.S. Department of Health and Human
Services, Food and Drug Administration/
Centers for Disease Control and Prevention,
‘‘Reducing the Risk of Listeria
monocytogenes FDA/CDC 2003 Update of the
Listeria Action Plan,’’ November 2003, http:/
/www.cfsan.fda.gov/~dms/lmr2plan.html.
4. U.S. Department of Health and Human
Services, Public Health Service, Food and
Drug Administration, Food Code, 2001, http:/
/www.cfsan.fda.gov/~dms/fc01–toc.html.
Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4217 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0058]
Hospira, Inc. et al.; Withdrawal of
Approval of 76 New Drug Applications
and 60 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\04MRN1.SGM
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ACTION:
Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 76 new drug applications
(NDAs) and 60 abbreviated new drug
applications (ANDAs) from multiple
applicants. 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: April 4, 2005.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
Application No.
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 requests, waived their
opportunity for a hearing.
SUPPLEMENTARY INFORMATION:
Drug
Applicant
NDA 6–095
Tubocurarine Chloride Injection
Hospira, Inc., 275 North Field Dr., Bldg. 2–J45–2,
Lake Forest, IL 60045–5046
NDA 6–412
Decapryn (doxylamine succinate) Tablets and
Syrup
Aventis Pharmaceuticals, Inc., 200 Crossing
Blvd., Bridgewater, NJ 08807–0890
NDA 6–460
Protamine Sulfate Injection USP
Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 8–032
Telepaque (iopanoic acid) Tablets
Amersham Health, 101 Carnegie Center, Princeton, NJ 08540
NDA 10–288
Betadine (10% povidone iodine) Solution and
Isodine (10% povidone iodine) Solution
The Purdue Frederick Co., One Stamford Forum,
Stamford, CT 06901–3431
NDA 11–097
Dimetane (brompheniramine maleate) Elixir
Wyeth Consumer Healthcare, Five Giralda
Farms, Madison, NJ 07940
NDA 11–270
Furoxone (furazolidone) Tablets
Shire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research
Blvd., suite 600, Rockville, MD 20850
NDA 11–323
Furoxone (furazolidone) Oral Suspension
Do.
NDA 11–325
Vesprin (triflupromazine hydrochloride (HCl)) Injection, 10 milligrams (mg)/milliliter (mL) and
20 mg/mL
Apothecon, c/o Bristol-Myers Squibb Co., P.O.
Box 4500, Princeton, NJ 08543–4500
NDA 11–367
Enzactin (triacetin) Spray
Wyeth Consumer Healthcare
NDA 12–265
Naqua (trichlormethiazide) Tablets and Naquival
(trichlormethiazide and reserpine) Tablets
Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 12–320
Rauzide (rauwolfia serpentine with
bendroflumethiazide) Tablets and Rautrax-N
Tablets
Apothecon, c/o Bristol-Myers Squibb Co.
NDA 12–728
Ortho-Novum 1/50–21 (norethindrone and
mestranol) Tablets
Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson
& Johnson Research and Development, L.L.C.,
920 Route 202 South, Box 300, Raritan, NJ
08869–0602
NDA 16–993
Adsorbotear Ophthalmic Solution
Alcon Laboratories, Inc., 6201 South Freeway,
Fort Worth, TX 76134
NDA 17–471
Sodium Pertechnetate Tc–99m (technetium Tc–
99m sodium pertechnetate) Solution
Amersham Health
NDA 17–488
Modicon 21 (norethindrone and ethinyl estradiol)
Tablets
Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson
& Johnson Research and Development, L.L.C.
NDA 17–489
Ortho-Novum 1/35–21 (norethindrone and ethinyl
estradiol) Tablets and Neocon Tablets
(norethindrone and ethinyl estradiol)
Do.
NDA 17–561
Celstone (betamethasone sodium phosphate
USP) Injection
Schering Corp.
NDA 17–601
Optimine (azatadine maleate USP) Tablets
Do.
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Application No.
Drug
Applicant
NDA 17–603
Novafed ER (pseudoephedrine HCl) Tablets, 120
mg
Aventis Pharmaceuticals, Inc.
NDA 17–657
Cephulac (lactulose fumarate) Syrup
Do.
NDA 17–661
Tavist (clemastine fumarate) Tablets and Tavist–
1 (clemastine fumarate) Tablets
Novartis Consumer Health, Inc., 200 Kimball Dr.,
Parsippany, NJ 07054–0622
NDA 17–687
Xenon Xe–133 Gas
Amersham Health
NDA 17–700
Gallium Citrate Ga–67 Injection
Do.
NDA 17–773
Technetium Tc–99m MAA Kit
Amersham Health
NDA 17–884
Chronulac (lactulose) Syrup
Aventis Pharmaceuticals, Inc.
NDA 18–030
Dextrose and Sodium Chloride (NaCl) Injection
USP
B. Braun Medical, Inc., 2525 McGaw Ave., P.O.
Box 19791, Irvine, CA 92623–9791
NDA 18–062
Proventil (albuterol sulfate) Syrup
Schering Corp.
NDA 18–229
Dextrose and NaCl Injection USP
B. Braun Medical, Inc.
NDA 18–269
Isolyte E (multi-electrolyte injection) with 5% Dextrose
Do.
NDA 18–270
Isolyte M (multi-electrolyte injection) with 5%
Dextrose
Do.
NDA 18–271
Isolyte R (multi-electrolyte injection) with 5%
Dextrose
Do.
NDA 18–273
Isolyte H (multi-electrolyte injection) with 5%
Dextrose
Do.
NDA 18–335
Amerscan (technetium Tc–99m medronate) MDP
Kit
Amersham Health
NDA 18–358
Dextrose Injection USP, 2.5%
B. Braun Medical, Inc.
NDA 18–386
Dextrose and NaCl Injection USP
Do.
NDA 18–506
Trinalin Repetabs (azatadine maleate and
pseudoephedrine sulfate tablets)
Schering Corp.
ANDA 18–621
Nitro-Bid IV (nitroglycerin) Injection, 5 mg/mL
Aventis Pharmaceuticals, Inc.
NDA 18–654
Versed (midazolam HCl) Injection
Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110–1199
NDA 18–675
Tavist (clemastine fumarate) Syrup
Novartis Consumer Health, Inc.
ANDA 18–889
Metronizadole in NaCl Injection
Abbott Laboratories, 200 Abbott Park Rd., D–389
J45–2, Abbott Park, IL 60064–6133
NDA 18–899
Isolyte E (multi-electrolyte injection)
B. Braun Medical, Inc.
NDA 18–924
Aminophylline in 0.45% NaCl Injection
Hospira, Inc.
NDA 18–967
Lidocaine HCl and 5% Dextrose Injection
B. Braun Medical, Inc.
NDA 19–004
Ortho-Novum (nonrethindrone and ethinyl estradiol) 7/14-21 and -28 Tablets
Ortho-McNeil Pharmaceuticals, Inc., c/o Johnson
& Johnson Research and Development, L.L.C.
NDA 19–006
Isolyte S, pH 7.4 (multi-electrolyte injection)
B. Braun Medical, Inc.
NDA 19–025
Isolyte P (multi-electrolyte injection) with 5% Dextrose Do.
NDA 19–033
Bretylium Tosylate Injection
Hospira, Inc.
NDA 19–042
Heparin Sodium in NaCl Injection
B. Braun Medical, Inc.
NDA 19–077
Sterile Water for Injection USP
Do.
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Application No.
Drug
Applicant
NDA 19–134
Heparin Sodium in 5% Dextrose Injection
Do.
NDA 19–135
Heparin Sodium in 0.9% NaCl Injection
Do.
NDA 19–243
Proventil (albuterol sulfate) Inhalation Solution
Schering Corp.
NDA 19–471
Cardizem SR Capsules (diltiazem HCl), 60 mg,
90 mg, 120 mg, and 180 mg
Biovail Laboratories, Inc., c/o Biovail Technologies Ltd., 700 Route 202/206 North,
Bridgewater, NJ 08807–0980
NDA 19–478
Adalat (nifedipine) Capsules
Bayer Pharmaceuticals Corp., 400 Morgan Lane,
West Haven, CT 06516–4175
NDA 19–604
Volmax (albuterol sulfate) Extended- Release
Tablets
Muro Pharmaceuticals, Inc., 890 East St.,
Tewksbury, MA 01876–1496
NDA 19–616
Penetrex (enoxacin) Tablets
Aventis Pharmaceuticals, Inc.
NDA 19–698
Toradol (ketorolac tromethamine) Injection
Roche Palo Alto, LLC, c/o Hoffman-La Roche,
Inc., 340 Kingsland St., Nutley, NJ 07110
NDA 19–817
Persantine (dipyridamole) Injection
Boehringer Ingleheim Pharmaceuticals, Inc., 900
Ridgebury Rd., P.O. Box 368, Ridgefield, CT
06877–0368
NDA 19–978
Bupivacaine HCl Injection USP
Hospira, Inc.
NDA 20–542
Dopamine HCl in 5% Dextrose Injection
Do.
NDA 20–677
Zagam (sparfloxacin) Tablets, 200 mg
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge
Rd., P.O. Box 4310, Morgantown, WV 26504–
4310
NDA 20–755
Caverject (alprostadil) Injection
Pfizer, Inc., 7000 Portage Rd., Kalamazoo, MI
49001
NDA 20–942
Versed (midazolam HCl) Syrup, 2 mg/mL
Hoffman-La Roche, Inc.
NDA 20–997
Chirocaine (levobupivacaine HCl) Injection
Purdue Pharma L.P., One Stamford Forum,
Stamford, CT 06901–3431
NDA 50–010
Ilosone (erythromycin estolate oral suspension)
Liquid
Eli Lilly & Co.
NDA 50–011
Pathocil (dicloxacillin sodium) Capsules
Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101–8299
NDA 50–199
Unipen (nafcillin sodium) Powder for Oral Solution
Do.
NDA 50–271
Achromycin (tetracycline HCl) Powder for Reconstitution
Lederle, c/o Wyeth Pharmaceuticals, P.O. Box
8299, Philadelphia, PA 19101–8299
NDA 50–320
Unipen (nafcillin sodium) Injection
Wyeth Pharmaceuticals
NDA 50–365
Ilosone (erythromycin estolate USP) Pulvules
Eli Lilly & Co.
NDA 50–369
Ilotycin (erythromycin) Tablets
Do.
NDA 50–426
Ilosone (erythromycin estolate USP) Tablets
Do.
NDA 50–427
Minocin (minocycline HCl) Diagnostic Susceptibility Powder
Lederle, c/o Wyeth Pharmaceuticals
NDA 50–437
Garamycin (gentamicin sulfate) Injection, 10 mg/
mL
Schering Corp.
NDA 50–462
Unipen (nafcillin sodium) Tablets
Wyeth Pharmaceuticals
NDA 50–505
Garamycin (gentamicin sulfate) Injection, 2 mg/
mL
Schering Corp.
NDA 50–549
Mezlin (mezlocillin sodium monohydrate) Sterile
Powder for Injection
Bayer Pharmaceuticals Corp.
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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
Application No.
Drug
Applicant
ANDA 60–134
Ledercillin VK (penicillin V potassium) Tablets,
250 mg and 500 mg
Lederle Laboratories, Pearl River, NY 10965
ANDA 60–136
Ledercillin VK (penicillin V potassium) for Oral
Suspension, 125 mg/5 mL and 250 mg/5 mL
Do.
ANDA 60–413
Penicillin G Potassium Tablets
Wyeth Laboratories
ANDA 60–431
Ilosone (erythromycin estolate USP) Chewable
Tablets
Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
ANDA 60–559
Ilosone (erythromycin estolate) Oral Suspension
Liquid
Do.
ANDA 60–625
Omnipen (ampicillin for oral suspension USP) for
Oral Suspension
Wyeth Laboratories
ANDA 60–626
Omnipen-N (ampicillin sodium) Injection, 125 mg,
250 mg, 500 mg, 1 gram (g), and 2 g/vial
Do.
ANDA 61–655
Kantrex (kanamycin sulfate) Injection
Apothecon, c/o Bristol-Myers Squibb Co.
ANDA 61–675
Wyamycin S (erythromycin stearate tablets USP),
250 mg and 500 mg
Wyeth Laboratories
ANDA 61–685
Tetracycline HCl Capsules USP, 250 mg and
500 mg
Do.
ANDA 61–769
Cephapirin for Injection USP
Apothecon, c/o Bristol-Myers Squibb Co.
ANDA 61–893
Ilosone (erythromycin estolate USP) for Oral
Suspension
Dista, c/o Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
ANDA 61–894
Ilosone (erythromycin estolate) Oral Suspension
Do.
ANDA 61–895
Ilosone (erythromycin estolate USP) Chewable
Tablets
Do.
ANDA 61–896
Ilosone (erythromycin estolate USP) Tablets
Do.
ANDA 61–897
Ilosone (erythromycin estolate USP) Pulvules
Do.
ANDA 61–910
Ilotycin (erythromycin) Enteric Coated Tablets
Do.
ANDA 62–123
Wyamycin E (erythromycin ethylsuccinate) Oral
Suspension, 200 mg/5 mL and 400 mg/5 mL
Wyeth Laboratories
ANDA 62–131
Wymox (amoxicillin) for Oral Suspension
Do.
ANDA 62–501
Gentacidin Ophthalmic Ointment (gentamicin sulfate ophthalmic ointment USP) 0.3%
Novartis Ophthalmics, Inc., 11695 John Creek
Pkwy., Duluth, GA 30097–1523
ANDA 62–544
Dexacidin (neomycin sulfate, polymyxin B sulfate,
and dexamethasone) Ophthalmic Suspension
Novartis Pharmaceuticals Corp., One Health
Plaza, Building 105 Eisenhower, East Hanover,
NJ 07936
ANDA 62–566
Dexacidin (neomycin sulfate, polymyxin B sulfate,
and dexamethasone) Ophthalmic Ointment
Novartis Ophthalmics, Inc.
ANDA 62–717
Unipen (nafcillin sodium) Injection, 500–mg, 1–g,
and 2–g vials
Wyeth Laboratories
ANDA 62–718
Omnipen-N (ampicillin sodium) Injection, 125–
mg, 250–mg, 500–mg, 1–g, and 2–g vials
Do.
ANDA 62–726
Kenamycin Sulfate Capsules USP, 500 mg
Apothecon, c/o Bristol-Myers Squibb Co.
ANDA 62–986
Cephalexin For Oral Suspension USP, 125 mg/5
mL
Do.
ANDA 63–107
Emgel (erythromycin) Topical Gel, 2%
GlalxoSmithKline Consumer Healthcare, L.P.,
1500 Littleton Rd., Parsippany, NJ 07054–
3884
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Application No.
Drug
Applicant
ANDA 71–159
Nitro-Bid (nitroglycerin) Injection, 10 mg/mL
Aventis Pharmaceuticals, Inc.
ANDA 74–194
Loperamide HCl Tablets, 2 mg
L. Perrigo Co., 515 Eastern Ave., Allegan, MI
49010
ANDA 74–539
Tamoxifen Citrate Tablets USP, 10 mg
Pharmachemie B.V., c/o Teva Pharmaceuticals,
1090 Horsham Rd., P.O. Box 1090, North
Wales, PA 19454–1090
ANDA 75–114
Acyclovir Injection, 50 mg/mL
Abbott Laboratories
ANDA 75–583
Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10
mg, and 20 mg
Apothecon Inc., c/o Bristol-Myers Squibb Co.
ANDA 75–729
Famotidine Injection, 0.4 mg/mL
Abbott Laboratories
ANDA 76–214
Sotalol HCl Tablets, 80 mg, 120 mg, and 160 mg
TorPharm, c/o Apotex Corp., 616 Heathrow Dr.,
Lincolnshire, IL 60069
ANDA 83–823
Nicolar (niacin) Tablets, 500 mg
Aventis Pharmaceuticals, Inc.
ANDA 83–892
Selenium Sulfide Lotion USP
Allergan, 2525 Dupont Dr., P.O. Box 19534,
Irvine, CA 92623
ANDA 84–476
Domeboro (acetic acid, glacial and aluminum acetate) SolutionBayer Pharmaceuticals Corp.
ANDA 85–113
Chlordiazepoxide HCl Capsules USP, 10 mg
Impax Laboratories, Inc., 30831 Huntwood Ave.,
Hayward, CA 94544
ANDA 85–187
Slo-Phyllin (theophylline) Syrup, 80 mg/15 mL
Aventis Pharmaceuticals, Inc.
ANDA 85–202
Slo-Phyllin (theophylline) Tablets, 100 mg
Do.
ANDA 85–204
Slo-Phyllin (theophylline) Tablets, 200 mg
Do.
ANDA 86–126
Nitrong SR (nitroglycerin) Tablets, 6.5 mg
Do.
ANDA 86–137
Nitrong (nitroglycerin) Ointment, 2%
Do.
ANDA 86–138
Nitrong (nitroglycerin) Tablets, 2.6 mg
Do.
ANDA 86–681
Acetaminophen and Codeine Phospate Tablets
USP, 300 mg/30 mg
Purepac Pharmaceutical Co., 200 Elmora Ave.,
Elizabeth, NJ 07207
ANDA 87–715
Nitrong SR (nitroglycerin) Tablets, 9 mg
Do.
ANDA 87–892
Slo-Bid (theophylline) Capsules, 100 mg
Aventis Pharmaceuticals, Inc.
ANDA 87–893
Slo-Bid (theophylline) Capsules, 200 mg
Do.
ANDA 87–894
Slo-Bid (theophylline) Capsules, 300 mg
Do.
ANDA 88–082
Hydrocortisone USP, Micronized Powder (Nonsterile)
Paddock Laboratories, Inc., 3940 Quebec Ave.
South, Minneapolis, MN 55427
ANDA 88–269
Slo-Bid (theophylline) Capsules, 50 mg
Aventis Pharmaceuticals, Inc.
ANDA 88–782
NTS 5 (nitroglycerin) Transdermal Systems
Hercon Laboratories Corp., 101 Sinking Springs
Lake, P.O. Box 467, Emigsville, PA 17318
ANDA 88–783
NTS 15 (nitroglycerin) Transdermal Systems
Do.
ANDA 88–791
Vasocidin (sulfacetamide sodium and prednisolone acetate) Ophthalmic Ointment
Novartis Ophthalmics, Inc.
ANDA 89–047
Sulf–15 (sulfacetamide sodium ophthalmic solution USP), 15%
Do.
ANDA 89–516
NTS 10 (nitroglycerin) Transdermal Systems
Hercon Laboratories Corp.
ANDA 89–539
Slo-Bid (theophylline) Capsules, 75 mg
Aventis Pharmaceuticals, Inc.
ANDA 89–540
Slo-Bid (theophylline) Capsules, 125 mg
Do.
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Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices
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, by the
Commissioner, approval of the
applications listed in the table in this
document, and all amendments and
supplements thereto, is hereby
withdrawn, effective April 4, 2005.
Dated: January 31, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation
and Research.
[FR Doc. 05–4158 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Submit written requests for
single copies of the revised guidance to
the Division of Compliance Policy
(HFC–230), Office of Enforcement, Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist
that office in processing your request or
include a fax number to which the
guidance may be sent.
Submit written comments on the
guidance to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
ADDRESSES:
[Docket No. 2003D–0554]
Revised Compliance Policy Guide
Regarding Prior Notice of Imported
Food Under the Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002; Availability
FOR FURTHER INFORMATION CONTACT:
Domenic Veneziano, Office of
Regulatory Affairs (HFC–100), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 703–621–
7809.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of draft revisions to
Compliance Policy Guide (CPG) Sec.
110.310 entitled ‘‘Prior Notice of
Imported Food Under the Public Health
Security and Bioterrorism Preparedness
and Response Act of 2002.’’ The CPG
provides written guidance to FDA and
Customs and Border Protection (CBP)
staff on enforcement of section 307 of
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) and the agency’s implementing
regulations, which require prior notice
for food imported or offered for import
into the United States. The CPG has
been revised to provide additional
guidance to FDA and CBP staff
regarding specific situations covering
routine shipments of food that are
transported through the United States,
arriving from and exiting to the same
country, and regarding the Harmonized
Tariff Schedule (HTS) code that is part
of the planned shipment information.
DATES: The draft revisions to the CPG
are found in section C, items 7 and 8.
Submit written or electronic comments
concerning the draft revisions to the
CPG by April 4, 2005. You may submit
written or electronic comments on the
other sections of the CPG at any time.
VerDate jul<14>2003
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II. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments on the revised CPG. Submit
a single copy of electronic copies or two
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in
brackets in the heading of this
document. The revised CPG and
received comments may be seen in the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
III. Electronic Access
An electronic version of the revised
CPG is available on the Internet at http:/
/www.fda.gov/ora under ‘‘Compliance
References.’’
Dated: February 24, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–4218 Filed 3–3–05; 8:45 am]
BILLING CODE 4160–01–S
I. Background
FDA is announcing the availability of
a draft revision to CPG Sec. 110.310
entitled ‘‘Prior Notice of Imported Food
Under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002.’’ This revised
guidance is issued with CBP
concurrence and explains to FDA and
CBP staff the new FDA and CBP policies
on enforcement of section 307 of the
Bioterrorism Act and its implementing
regulations, which require prior notice
to FDA of all food imported or offered
for import into the United States (21
CFR part 1.276 through 1.285).
FDA is considering taking these steps
while the prior notice final rule is under
development to provide additional
flexibility in filing prior notice when,
due to the geography, the only practical
transportation route available for the
shipment is through the United States
and when there is a prior notice
violation because the prior notice does
not include the 6-digit HTS code for the
article of food.
FDA is issuing the revisions to the
CPG as level 1 draft guidance consistent
with FDA’s good guidance practices
regulation § 10.115 (21 CFR 10.115). The
draft revisions to the CPG represent the
agency’s current thinking on its
enforcement policy concerning prior
notice. It does not create or confer any
rights for or on any person and does not
operate to bind FDA or the public. The
draft revisions to the CPG are found in
section C, items 7 and 8.
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Organ
Transplantation; Request for
Nominations for Voting Members
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
SUMMARY: The Health Resources and
Services Administration (HRSA) is
requesting nominations to fill up to 13
vacancies on the Advisory Committee
on Organ Transplantation (ACOT). The
ACOT was established by the Amended
Final Rule of the Organ Procurement
and Transplantation Network (OPTN)
(42 CFR Part 121) and, in accordance
with Pub. L. 92–463, was chartered on
September 1, 2000.
DATES: The agency must receive
nominations on or before April 4, 2005.
ADDRESSES: All nominations should be
submitted to the Executive Director,
Advisory Committee on Organ
Transplantation, Healthcare Systems
Bureau, HRSA, Parklawn Building,
Room 12C–06, 5600 Fishers Lane,
Rockville, Maryland 20857. Federal
Express, Airborne, UPS, etc., mail
delivery should be addressed to
Executive Director, Advisory Committee
on Organ Transplantation, Healthcare
Systems Bureau, HRSA, at the above
address.
E:\FR\FM\04MRN1.SGM
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]]>Agencies
[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10651-10657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4158]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0058]
Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug
Applications and 60 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
[[Page 10652]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing
approval of 76 new drug applications (NDAs) and 60 abbreviated new drug
applications (ANDAs) from multiple applicants. 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: April 4, 2005.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, 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 requests, waived
their opportunity for a hearing.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 6-095 Tubocurarine Chloride Hospira, Inc., 275 North
Injection Field Dr., Bldg. 2-J45-
2, Lake Forest, IL
60045-5046
------------------------------------------------------------------------
NDA 6-412 Decapryn (doxylamine Aventis Pharmaceuticals,
succinate) Tablets and Inc., 200 Crossing
Syrup Blvd., Bridgewater, NJ
08807-0890
------------------------------------------------------------------------
NDA 6-460 Protamine Sulfate Eli Lilly and Co., Lilly
Injection USP Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
NDA 8-032 Telepaque (iopanoic Amersham Health, 101
acid) Tablets Carnegie Center,
Princeton, NJ 08540
------------------------------------------------------------------------
NDA 10-288 Betadine (10% povidone The Purdue Frederick
iodine) Solution and Co., One Stamford
Isodine (10% povidone Forum, Stamford, CT
iodine) Solution 06901-3431
------------------------------------------------------------------------
NDA 11-097 Dimetane Wyeth Consumer
(brompheniramine Healthcare, Five
maleate) Elixir Giralda Farms, Madison,
NJ 07940
------------------------------------------------------------------------
NDA 11-270 Furoxone (furazolidone) Shire Laboratories,
Tablets Inc., c/o Shire
Pharmaceutical
Development, Inc., 1801
Research Blvd., suite
600, Rockville, MD
20850
------------------------------------------------------------------------
NDA 11-323 Furoxone (furazolidone) Do.
Oral Suspension
------------------------------------------------------------------------
NDA 11-325 Vesprin (triflupromazine Apothecon, c/o Bristol-
hydrochloride (HCl)) Myers Squibb Co., P.O.
Injection, 10 Box 4500, Princeton, NJ
milligrams (mg)/ 08543-4500
milliliter (mL) and 20
mg/mL
------------------------------------------------------------------------
NDA 11-367 Enzactin (triacetin) Wyeth Consumer
Spray Healthcare
------------------------------------------------------------------------
NDA 12-265 Naqua Schering Corp., 2000
(trichlormethiazide) Galloping Hill Rd.,
Tablets and Naquival Kenilworth, NJ 07033
(trichlormethiazide and
reserpine) Tablets
------------------------------------------------------------------------
NDA 12-320 Rauzide (rauwolfia Apothecon, c/o Bristol-
serpentine with Myers Squibb Co.
bendroflumethiazide)
Tablets and Rautrax-N
Tablets
------------------------------------------------------------------------
NDA 12-728 Ortho-Novum 1/50-21 Ortho-McNeil
(norethindrone and Pharmaceuticals, Inc.,
mestranol) Tablets c/o Johnson & Johnson
Research and
Development, L.L.C.,
920 Route 202 South,
Box 300, Raritan, NJ
08869-0602
------------------------------------------------------------------------
NDA 16-993 Adsorbotear Ophthalmic Alcon Laboratories,
Solution Inc., 6201 South
Freeway, Fort Worth, TX
76134
------------------------------------------------------------------------
NDA 17-471 Sodium Pertechnetate Tc- Amersham Health
99m (technetium Tc-99m
sodium pertechnetate)
Solution
------------------------------------------------------------------------
NDA 17-488 Modicon 21 Ortho-McNeil
(norethindrone and Pharmaceuticals, Inc.,
ethinyl estradiol) c/o Johnson & Johnson
Tablets Research and
Development, L.L.C.
------------------------------------------------------------------------
NDA 17-489 Ortho-Novum 1/35-21 Do.
(norethindrone and
ethinyl estradiol)
Tablets and Neocon
Tablets (norethindrone
and ethinyl estradiol)
------------------------------------------------------------------------
NDA 17-561 Celstone (betamethasone Schering Corp.
sodium phosphate USP)
Injection
------------------------------------------------------------------------
NDA 17-601 Optimine (azatadine Do.
maleate USP) Tablets
------------------------------------------------------------------------
[[Page 10653]]
NDA 17-603 Novafed ER Aventis Pharmaceuticals,
(pseudoephedrine HCl) Inc.
Tablets, 120 mg
------------------------------------------------------------------------
NDA 17-657 Cephulac (lactulose Do.
fumarate) Syrup
------------------------------------------------------------------------
NDA 17-661 Tavist (clemastine Novartis Consumer
fumarate) Tablets and Health, Inc., 200
Tavist-1 (clemastine Kimball Dr.,
fumarate) Tablets Parsippany, NJ 07054-
0622
------------------------------------------------------------------------
NDA 17-687 Xenon Xe-133 Gas Amersham Health
------------------------------------------------------------------------
NDA 17-700 Gallium Citrate Ga-67 Do.
Injection
------------------------------------------------------------------------
NDA 17-773 Technetium Tc-99m MAA Amersham Health
Kit
------------------------------------------------------------------------
NDA 17-884 Chronulac (lactulose) Aventis Pharmaceuticals,
Syrup Inc.
------------------------------------------------------------------------
NDA 18-030 Dextrose and Sodium B. Braun Medical, Inc.,
Chloride (NaCl) 2525 McGaw Ave., P.O.
Injection USP Box 19791, Irvine, CA
92623-9791
------------------------------------------------------------------------
NDA 18-062 Proventil (albuterol Schering Corp.
sulfate) Syrup
------------------------------------------------------------------------
NDA 18-229 Dextrose and NaCl B. Braun Medical, Inc.
Injection USP
------------------------------------------------------------------------
NDA 18-269 Isolyte E (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-270 Isolyte M (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-271 Isolyte R (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-273 Isolyte H (multi- Do.
electrolyte injection)
with 5% Dextrose
------------------------------------------------------------------------
NDA 18-335 Amerscan (technetium Tc- Amersham Health
99m medronate) MDP Kit
------------------------------------------------------------------------
NDA 18-358 Dextrose Injection USP, B. Braun Medical, Inc.
2.5%
------------------------------------------------------------------------
NDA 18-386 Dextrose and NaCl Do.
Injection USP
------------------------------------------------------------------------
NDA 18-506 Trinalin Repetabs Schering Corp.
(azatadine maleate and
pseudoephedrine sulfate
tablets)
------------------------------------------------------------------------
ANDA 18-621 Nitro-Bid IV Aventis Pharmaceuticals,
(nitroglycerin) Inc.
Injection, 5 mg/mL
------------------------------------------------------------------------
NDA 18-654 Versed (midazolam HCl) Hoffman-La Roche, Inc.,
Injection 340 Kingsland St.,
Nutley, NJ 07110-1199
------------------------------------------------------------------------
NDA 18-675 Tavist (clemastine Novartis Consumer
fumarate) Syrup Health, Inc.
------------------------------------------------------------------------
ANDA 18-889 Metronizadole in NaCl Abbott Laboratories, 200
Injection Abbott Park Rd., D-389
J45-2, Abbott Park, IL
60064-6133
------------------------------------------------------------------------
NDA 18-899 Isolyte E (multi- B. Braun Medical, Inc.
electrolyte injection)
------------------------------------------------------------------------
NDA 18-924 Aminophylline in 0.45% Hospira, Inc.
NaCl Injection
------------------------------------------------------------------------
NDA 18-967 Lidocaine HCl and 5% B. Braun Medical, Inc.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-004 Ortho-Novum Ortho-McNeil
(nonrethindrone and Pharmaceuticals, Inc.,
ethinyl estradiol) 7/14- c/o Johnson & Johnson
21 and -28 Tablets Research and
Development, L.L.C.
------------------------------------------------------------------------
NDA 19-006 Isolyte S, pH 7.4 (multi- B. Braun Medical, Inc.
electrolyte injection)
------------------------------------------------------------------------
NDA 19-025 Isolyte P (multi-
electrolyte injection)
with 5% Dextrose Do.
------------------------------------------------------------------------
NDA 19-033 Bretylium Tosylate Hospira, Inc.
Injection
------------------------------------------------------------------------
NDA 19-042 Heparin Sodium in NaCl B. Braun Medical, Inc.
Injection
------------------------------------------------------------------------
NDA 19-077 Sterile Water for Do.
Injection USP
------------------------------------------------------------------------
[[Page 10654]]
NDA 19-134 Heparin Sodium in 5% Do.
Dextrose Injection
------------------------------------------------------------------------
NDA 19-135 Heparin Sodium in 0.9% Do.
NaCl Injection
------------------------------------------------------------------------
NDA 19-243 Proventil (albuterol Schering Corp.
sulfate) Inhalation
Solution
------------------------------------------------------------------------
NDA 19-471 Cardizem SR Capsules Biovail Laboratories,
(diltiazem HCl), 60 mg, Inc., c/o Biovail
90 mg, 120 mg, and 180 Technologies Ltd., 700
mg Route 202/206 North,
Bridgewater, NJ 08807-
0980
------------------------------------------------------------------------
NDA 19-478 Adalat (nifedipine) Bayer Pharmaceuticals
Capsules Corp., 400 Morgan Lane,
West Haven, CT 06516-
4175
------------------------------------------------------------------------
NDA 19-604 Volmax (albuterol Muro Pharmaceuticals,
sulfate) Extended- Inc., 890 East St.,
Release Tablets Tewksbury, MA 01876-
1496
------------------------------------------------------------------------
NDA 19-616 Penetrex (enoxacin) Aventis Pharmaceuticals,
Tablets Inc.
------------------------------------------------------------------------
NDA 19-698 Toradol (ketorolac Roche Palo Alto, LLC, c/
tromethamine) Injection o Hoffman-La Roche,
Inc., 340 Kingsland
St., Nutley, NJ 07110
------------------------------------------------------------------------
NDA 19-817 Persantine Boehringer Ingleheim
(dipyridamole) Pharmaceuticals, Inc.,
Injection 900 Ridgebury Rd., P.O.
Box 368, Ridgefield, CT
06877-0368
------------------------------------------------------------------------
NDA 19-978 Bupivacaine HCl Hospira, Inc.
Injection USP
------------------------------------------------------------------------
NDA 20-542 Dopamine HCl in 5% Do.
Dextrose Injection
------------------------------------------------------------------------
NDA 20-677 Zagam (sparfloxacin) Mylan Pharmaceuticals,
Tablets, 200 mg Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26504-4310
------------------------------------------------------------------------
NDA 20-755 Caverject (alprostadil) Pfizer, Inc., 7000
Injection Portage Rd., Kalamazoo,
MI 49001
------------------------------------------------------------------------
NDA 20-942 Versed (midazolam HCl) Hoffman-La Roche, Inc.
Syrup, 2 mg/mL
------------------------------------------------------------------------
NDA 20-997 Chirocaine Purdue Pharma L.P., One
(levobupivacaine HCl) Stamford Forum,
Injection Stamford, CT 06901-3431
------------------------------------------------------------------------
NDA 50-010 Ilosone (erythromycin Eli Lilly & Co.
estolate oral
suspension) Liquid
------------------------------------------------------------------------
NDA 50-011 Pathocil (dicloxacillin Wyeth Pharmaceuticals,
sodium) Capsules P.O. Box 8299,
Philadelphia, PA 19101-
8299
------------------------------------------------------------------------
NDA 50-199 Unipen (nafcillin Do.
sodium) Powder for Oral
Solution
------------------------------------------------------------------------
NDA 50-271 Achromycin (tetracycline Lederle, c/o Wyeth
HCl) Powder for Pharmaceuticals, P.O.
Reconstitution Box 8299, Philadelphia,
PA 19101-8299
------------------------------------------------------------------------
NDA 50-320 Unipen (nafcillin Wyeth Pharmaceuticals
sodium) Injection
------------------------------------------------------------------------
NDA 50-365 Ilosone (erythromycin Eli Lilly & Co.
estolate USP) Pulvules
------------------------------------------------------------------------
NDA 50-369 Ilotycin (erythromycin) Do.
Tablets
------------------------------------------------------------------------
NDA 50-426 Ilosone (erythromycin Do.
estolate USP) Tablets
------------------------------------------------------------------------
NDA 50-427 Minocin (minocycline Lederle, c/o Wyeth
HCl) Diagnostic Pharmaceuticals
Susceptibility Powder
------------------------------------------------------------------------
NDA 50-437 Garamycin (gentamicin Schering Corp.
sulfate) Injection, 10
mg/mL
------------------------------------------------------------------------
NDA 50-462 Unipen (nafcillin Wyeth Pharmaceuticals
sodium) Tablets
------------------------------------------------------------------------
NDA 50-505 Garamycin (gentamicin Schering Corp.
sulfate) Injection, 2
mg/mL
------------------------------------------------------------------------
NDA 50-549 Mezlin (mezlocillin Bayer Pharmaceuticals
sodium monohydrate) Corp.
Sterile Powder for
Injection
------------------------------------------------------------------------
[[Page 10655]]
ANDA 60-134 Ledercillin VK Lederle Laboratories,
(penicillin V Pearl River, NY 10965
potassium) Tablets, 250
mg and 500 mg
------------------------------------------------------------------------
ANDA 60-136 Ledercillin VK Do.
(penicillin V
potassium) for Oral
Suspension, 125 mg/5 mL
and 250 mg/5 mL
------------------------------------------------------------------------
ANDA 60-413 Penicillin G Potassium Wyeth Laboratories
Tablets
------------------------------------------------------------------------
ANDA 60-431 Ilosone (erythromycin Lilly Research
estolate USP) Chewable Laboratories, Lilly
Tablets Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 60-559 Ilosone (erythromycin Do.
estolate) Oral
Suspension Liquid
------------------------------------------------------------------------
ANDA 60-625 Omnipen (ampicillin for Wyeth Laboratories
oral suspension USP)
for Oral Suspension
------------------------------------------------------------------------
ANDA 60-626 Omnipen-N (ampicillin Do.
sodium) Injection, 125
mg, 250 mg, 500 mg, 1
gram (g), and 2 g/vial
------------------------------------------------------------------------
ANDA 61-655 Kantrex (kanamycin Apothecon, c/o Bristol-
sulfate) Injection Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-675 Wyamycin S (erythromycin Wyeth Laboratories
stearate tablets USP),
250 mg and 500 mg
------------------------------------------------------------------------
ANDA 61-685 Tetracycline HCl Do.
Capsules USP, 250 mg
and 500 mg
------------------------------------------------------------------------
ANDA 61-769 Cephapirin for Injection Apothecon, c/o Bristol-
USP Myers Squibb Co.
------------------------------------------------------------------------
ANDA 61-893 Ilosone (erythromycin Dista, c/o Lilly
estolate USP) for Oral Research Laboratories,
Suspension Lilly Corporate Center,
Indianapolis, IN 46285
------------------------------------------------------------------------
ANDA 61-894 Ilosone (erythromycin Do.
estolate) Oral
Suspension
------------------------------------------------------------------------
ANDA 61-895 Ilosone (erythromycin Do.
estolate USP) Chewable
Tablets
------------------------------------------------------------------------
ANDA 61-896 Ilosone (erythromycin Do.
estolate USP) Tablets
------------------------------------------------------------------------
ANDA 61-897 Ilosone (erythromycin Do.
estolate USP) Pulvules
------------------------------------------------------------------------
ANDA 61-910 Ilotycin (erythromycin) Do.
Enteric Coated Tablets
------------------------------------------------------------------------
ANDA 62-123 Wyamycin E (erythromycin Wyeth Laboratories
ethylsuccinate) Oral
Suspension, 200 mg/5 mL
and 400 mg/5 mL
------------------------------------------------------------------------
ANDA 62-131 Wymox (amoxicillin) for Do.
Oral Suspension
------------------------------------------------------------------------
ANDA 62-501 Gentacidin Ophthalmic Novartis Ophthalmics,
Ointment (gentamicin Inc., 11695 John Creek
sulfate ophthalmic Pkwy., Duluth, GA 30097-
ointment USP) 0.3% 1523
------------------------------------------------------------------------
ANDA 62-544 Dexacidin (neomycin Novartis Pharmaceuticals
sulfate, polymyxin B Corp., One Health
sulfate, and Plaza, Building 105
dexamethasone) Eisenhower, East
Ophthalmic Suspension Hanover, NJ 07936
------------------------------------------------------------------------
ANDA 62-566 Dexacidin (neomycin Novartis Ophthalmics,
sulfate, polymyxin B Inc.
sulfate, and
dexamethasone)
Ophthalmic Ointment
------------------------------------------------------------------------
ANDA 62-717 Unipen (nafcillin Wyeth Laboratories
sodium) Injection, 500-
mg, 1-g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-718 Omnipen-N (ampicillin Do.
sodium) Injection, 125-
mg, 250-mg, 500-mg, 1-
g, and 2-g vials
------------------------------------------------------------------------
ANDA 62-726 Kenamycin Sulfate Apothecon, c/o Bristol-
Capsules USP, 500 mg Myers Squibb Co.
------------------------------------------------------------------------
ANDA 62-986 Cephalexin For Oral Do.
Suspension USP, 125 mg/
5 mL
------------------------------------------------------------------------
ANDA 63-107 Emgel (erythromycin) GlalxoSmithKline
Topical Gel, 2% Consumer Healthcare,
L.P., 1500 Littleton
Rd., Parsippany, NJ
07054-3884
------------------------------------------------------------------------
[[Page 10656]]
ANDA 71-159 Nitro-Bid Aventis Pharmaceuticals,
(nitroglycerin) Inc.
Injection, 10 mg/mL
------------------------------------------------------------------------
ANDA 74-194 Loperamide HCl Tablets, L. Perrigo Co., 515
2 mg Eastern Ave., Allegan,
MI 49010
------------------------------------------------------------------------
ANDA 74-539 Tamoxifen Citrate Pharmachemie B.V., c/o
Tablets USP, 10 mg Teva Pharmaceuticals,
1090 Horsham Rd., P.O.
Box 1090, North Wales,
PA 19454-1090
------------------------------------------------------------------------
ANDA 75-114 Acyclovir Injection, 50 Abbott Laboratories
mg/mL
------------------------------------------------------------------------
ANDA 75-583 Enalapril Maleate Apothecon Inc., c/o
Tablets USP, 2.5 mg, 5 Bristol-Myers Squibb
mg, 10 mg, and 20 mg Co.
------------------------------------------------------------------------
ANDA 75-729 Famotidine Injection, Abbott Laboratories
0.4 mg/mL
------------------------------------------------------------------------
ANDA 76-214 Sotalol HCl Tablets, 80 TorPharm, c/o Apotex
mg, 120 mg, and 160 mg Corp., 616 Heathrow
Dr., Lincolnshire, IL
60069
------------------------------------------------------------------------
ANDA 83-823 Nicolar (niacin) Aventis Pharmaceuticals,
Tablets, 500 mg Inc.
------------------------------------------------------------------------
ANDA 83-892 Selenium Sulfide Lotion Allergan, 2525 Dupont
USP Dr., P.O. Box 19534,
Irvine, CA 92623
------------------------------------------------------------------------
ANDA 84-476 Domeboro (acetic acid,
glacial and aluminum
acetate) SolutionBayer
Pharmaceuticals Corp.
------------------------------------------------------------------------
ANDA 85-113 Chlordiazepoxide HCl Impax Laboratories,
Capsules USP, 10 mg Inc., 30831 Huntwood
Ave., Hayward, CA 94544
------------------------------------------------------------------------
ANDA 85-187 Slo-Phyllin Aventis Pharmaceuticals,
(theophylline) Syrup, Inc.
80 mg/15 mL
------------------------------------------------------------------------
ANDA 85-202 Slo-Phyllin Do.
(theophylline) Tablets,
100 mg
------------------------------------------------------------------------
ANDA 85-204 Slo-Phyllin Do.
(theophylline) Tablets,
200 mg
------------------------------------------------------------------------
ANDA 86-126 Nitrong SR Do.
(nitroglycerin)
Tablets, 6.5 mg
------------------------------------------------------------------------
ANDA 86-137 Nitrong (nitroglycerin) Do.
Ointment, 2%
------------------------------------------------------------------------
ANDA 86-138 Nitrong (nitroglycerin) Do.
Tablets, 2.6 mg
------------------------------------------------------------------------
ANDA 86-681 Acetaminophen and Purepac Pharmaceutical
Codeine Phospate Co., 200 Elmora Ave.,
Tablets USP, 300 mg/30 Elizabeth, NJ 07207
mg
------------------------------------------------------------------------
ANDA 87-715 Nitrong SR Do.
(nitroglycerin)
Tablets, 9 mg
------------------------------------------------------------------------
ANDA 87-892 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 100 mg Inc.
------------------------------------------------------------------------
ANDA 87-893 Slo-Bid (theophylline) Do.
Capsules, 200 mg
------------------------------------------------------------------------
ANDA 87-894 Slo-Bid (theophylline) Do.
Capsules, 300 mg
------------------------------------------------------------------------
ANDA 88-082 Hydrocortisone USP, Paddock Laboratories,
Micronized Powder Inc., 3940 Quebec Ave.
(Nonsterile) South, Minneapolis, MN
55427
------------------------------------------------------------------------
ANDA 88-269 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 50 mg Inc.
------------------------------------------------------------------------
ANDA 88-782 NTS 5 (nitroglycerin) Hercon Laboratories
Transdermal Systems Corp., 101 Sinking
Springs Lake, P.O. Box
467, Emigsville, PA
17318
------------------------------------------------------------------------
ANDA 88-783 NTS 15 (nitroglycerin) Do.
Transdermal Systems
------------------------------------------------------------------------
ANDA 88-791 Vasocidin (sulfacetamide Novartis Ophthalmics,
sodium and prednisolone Inc.
acetate) Ophthalmic
Ointment
------------------------------------------------------------------------
ANDA 89-047 Sulf-15 (sulfacetamide Do.
sodium ophthalmic
solution USP), 15%
------------------------------------------------------------------------
ANDA 89-516 NTS 10 (nitroglycerin) Hercon Laboratories
Transdermal Systems Corp.
------------------------------------------------------------------------
ANDA 89-539 Slo-Bid (theophylline) Aventis Pharmaceuticals,
Capsules, 75 mg Inc.
------------------------------------------------------------------------
ANDA 89-540 Slo-Bid (theophylline) Do.
Capsules, 125 mg
------------------------------------------------------------------------
[[Page 10657]]
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, by the Commissioner,
approval of the applications listed in the table in this document, and
all amendments and supplements thereto, is hereby withdrawn, effective
April 4, 2005.
Dated: January 31, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-4158 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S
