DE60130801D1 - In der mundhöhle schnell zerfallende orale arzneizubereitung enthaltend einen cyclooxygenase-2 hemmer - Google Patents

In der mundhöhle schnell zerfallende orale arzneizubereitung enthaltend einen cyclooxygenase-2 hemmer

Info

Publication number
DE60130801D1
DE60130801D1 DE60130801T DE60130801T DE60130801D1 DE 60130801 D1 DE60130801 D1 DE 60130801D1 DE 60130801 T DE60130801 T DE 60130801T DE 60130801 T DE60130801 T DE 60130801T DE 60130801 D1 DE60130801 D1 DE 60130801D1
Authority
DE
Germany
Prior art keywords
cyclooxygenase
hemmer
medicine preparation
preparation containing
oral medicine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
DE60130801T
Other languages
English (en)
Other versions
DE60130801T2 (de
Inventor
Trang T Le
Tugrul T Kararli
Mark J Kontny
Srikonda V Sastry
Janaki R Nyshadham
Arthur J Pagliero
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pharmacia LLC
Astellas Pharma Technologies Inc
Original Assignee
Yamanouchi Pharma Technologies Inc
Pharmacia LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Yamanouchi Pharma Technologies Inc, Pharmacia LLC filed Critical Yamanouchi Pharma Technologies Inc
Application granted granted Critical
Publication of DE60130801D1 publication Critical patent/DE60130801D1/de
Publication of DE60130801T2 publication Critical patent/DE60130801T2/de
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4151,2-Diazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47Quinolines; Isoquinolines
    • A61K31/485Morphinan derivatives, e.g. morphine, codeine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • A61P27/06Antiglaucoma agents or miotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A61P29/02Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Ophthalmology & Optometry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Pulmonology (AREA)
  • Endocrinology (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Emergency Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Cardiology (AREA)
  • Reproductive Health (AREA)
  • Dermatology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DE60130801T 2000-08-18 2001-08-17 In der mundhöhle schnell zerfallende orale arzneizubereitung enthaltend einen cyclooxygenase-2 hemmer Expired - Fee Related DE60130801T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US22634700P 2000-08-18 2000-08-18
US226347P 2000-08-18
PCT/US2001/025803 WO2002015885A2 (en) 2000-08-18 2001-08-17 Oral fast-melt formulation of a cyclooxygenase-2 inhibitor

Publications (2)

Publication Number Publication Date
DE60130801D1 true DE60130801D1 (de) 2007-11-15
DE60130801T2 DE60130801T2 (de) 2008-06-26

Family

ID=22848576

Family Applications (1)

Application Number Title Priority Date Filing Date
DE60130801T Expired - Fee Related DE60130801T2 (de) 2000-08-18 2001-08-17 In der mundhöhle schnell zerfallende orale arzneizubereitung enthaltend einen cyclooxygenase-2 hemmer

Country Status (20)

Country Link
US (1) US20020049233A1 (de)
EP (2) EP1309316A2 (de)
JP (2) JP2004512274A (de)
KR (1) KR20030045035A (de)
CN (1) CN1638739A (de)
AT (1) ATE374599T1 (de)
AU (3) AU2001286530B2 (de)
BR (1) BR0113293A (de)
CA (2) CA2420190A1 (de)
CZ (1) CZ2003422A3 (de)
DE (1) DE60130801T2 (de)
DK (1) DK1355631T3 (de)
ES (1) ES2292614T3 (de)
IL (1) IL154386A0 (de)
MX (2) MXPA03001408A (de)
NO (1) NO20030727L (de)
NZ (2) NZ524115A (de)
PL (1) PL360704A1 (de)
PT (1) PT1355631E (de)
WO (2) WO2002015885A2 (de)

Families Citing this family (24)

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CA2445502A1 (en) * 2001-05-04 2002-11-14 Merck & Co., Inc. Method and compositions for treating migraines
CA2461630A1 (en) * 2001-09-26 2003-04-03 Trang T. Le Organoleptically acceptable intraorally disintegrating compositions
OA12666A (en) * 2001-10-10 2006-06-19 Pharmacia Corp Corporate Paten Intraorally disintegrating valdecoxib compositionsprepared by spray drying process.
MXPA04004290A (es) * 2001-11-07 2004-08-11 Pharmacia Corp Composiciones de valdecoxib que se disgregan intraoralmente preparadas mediante un procedimiento de granulacion en lecho fluido.
US7838029B1 (en) * 2003-07-31 2010-11-23 Watson Laboratories, Inc. Mirtazapine solid dosage forms
JP2008518942A (ja) * 2004-11-04 2008-06-05 メルク エンド カムパニー インコーポレーテッド 粒子の顆粒化方法
JP4945917B2 (ja) * 2005-01-19 2012-06-06 大正製薬株式会社 薬物含有コーティング用核粒子
EP3782655A1 (de) * 2005-05-17 2021-02-24 Amicus Therapeutics, Inc. Verfahren zur behandlung der pompe-krankheit unter verwendung von 1-deoxynojirimycin und derivaten
KR20070067173A (ko) * 2005-08-29 2007-06-27 테바 파마슈티컬 인더스트리즈 리미티드 이정점 입도 분포를 갖는 고체 미립자 타달라필
US7811604B1 (en) 2005-11-14 2010-10-12 Barr Laboratories, Inc. Non-effervescent, orally disintegrating solid pharmaceutical dosage forms comprising clozapine and methods of making and using the same
CA2632039A1 (en) * 2005-12-23 2007-06-28 Lek Pharmaceuticals D.D. Bursting pellets
US20100233272A1 (en) * 2007-11-15 2010-09-16 Leah Elizabeth Appel Dosage forms comprising celecoxib providing both rapid and sustained pain relief
KR20230066482A (ko) 2012-03-07 2023-05-15 아미쿠스 세라퓨틱스, 인코포레이티드 폼페병의 치료를 위한 고농도 알파-글루코시다제 조성물
CN104027319A (zh) * 2014-06-25 2014-09-10 万特制药(海南)有限公司 一种塞来昔布分散片及其制备方法
CN107075468B (zh) 2014-09-30 2021-12-24 阿米库斯治疗学公司 具有增强的碳水化合物的高强度酸性α-葡糖苷酶
WO2017117407A1 (en) 2015-12-30 2017-07-06 Amicus Therapeutics, Inc. Augmented acid alpha-glucosidase for the treatment of pompe disease
CA3019128A1 (en) 2016-03-30 2017-10-05 Amicus Therapeutics, Inc. Formulations comprising recombinant acid alpha-glucosidase
IL295551A (en) 2016-03-30 2022-10-01 Amicus Therapeutics Inc A method for selecting recombinant proteins with a high amount of mannose-6-phosphate
US10350171B2 (en) 2017-07-06 2019-07-16 Dexcel Ltd. Celecoxib and amlodipine formulation and method of making the same
CN108576205B (zh) * 2018-03-22 2022-01-04 湖北省农业科学院农产品加工与核农技术研究所 一种草莓联合干燥的处理方法
WO2020106522A1 (en) 2018-11-21 2020-05-28 Tremeau Pharmaceuticals, Inc. Purified forms of rofecoxib, methods of manufacture and use
JP2020183359A (ja) * 2019-05-09 2020-11-12 日医工株式会社 セレコキシブ含有医薬組成物
US10945992B1 (en) 2019-11-13 2021-03-16 Tremeau Pharmaceuticals, Inc. Dosage forms of rofecoxib and related methods
US11161833B1 (en) 2021-04-09 2021-11-02 Tremeau Pharmaceuticals, Inc. Deuterated etoricoxib, methods of manufacture, and use thereof

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUT74908A (en) * 1994-01-31 1997-03-28 Yamanouchi Pharma Co Ltd Intraorally soluble compressed molding and process for producing the same
US5633272A (en) * 1995-02-13 1997-05-27 Talley; John J. Substituted isoxazoles for the treatment of inflammation
SK74396A3 (en) * 1995-06-13 1997-04-09 American Home Prod Organoleptically acceptable oral pharmaceutical compositions
CA2254061C (en) * 1996-05-17 2003-12-02 Merck & Co., Inc. Compositions for a once a day treatment of cyclooxygenase-2 mediated diseases
US5958453A (en) * 1996-10-31 1999-09-28 Takeda Chemical Industries, Ltd. Solid pharmaceutical preparation with improved buccal disintegrability and/or dissolubility
IT1293764B1 (it) * 1997-07-23 1999-03-10 Chiesi Farma Spa Composizioni farmaceutiche sotto forma di compresse effervescenti contenenti un principio attivo instabile in presenza di acqua
US6465009B1 (en) * 1998-03-18 2002-10-15 Yamanouchi Pharmaceutical Co., Ltd. Water soluble polymer-based rapidly dissolving tablets and production processes thereof
SA99191255B1 (ar) * 1998-11-30 2006-11-25 جي دي سيرل اند كو مركبات سيليكوكسيب celecoxib
PL351069A1 (en) * 1999-12-08 2003-03-10 Pharmacia Corp Valdecoxib compositions
US6316029B1 (en) * 2000-05-18 2001-11-13 Flak Pharma International, Ltd. Rapidly disintegrating solid oral dosage form
OA12686A (en) * 2001-02-27 2006-06-21 Ranbaxy Lab Ltd Fast dissolving tablets of cyclooxygenase-2 enzymeinhibitors.

Also Published As

Publication number Publication date
MXPA03001346A (es) 2003-06-06
CZ2003422A3 (cs) 2003-06-18
JP2004506681A (ja) 2004-03-04
EP1355631B1 (de) 2007-10-03
NO20030727D0 (no) 2003-02-14
AU8653001A (en) 2002-03-04
ATE374599T1 (de) 2007-10-15
PL360704A1 (en) 2004-09-20
AU2001286530B2 (en) 2007-01-25
CA2418730A1 (en) 2002-02-28
DE60130801T2 (de) 2008-06-26
WO2002015886A2 (en) 2002-02-28
ES2292614T3 (es) 2008-03-16
CN1638739A (zh) 2005-07-13
WO2002015886A3 (en) 2002-07-25
BR0113293A (pt) 2003-06-10
PT1355631E (pt) 2007-11-29
MXPA03001408A (es) 2005-06-30
EP1355631A2 (de) 2003-10-29
CA2420190A1 (en) 2002-02-28
EP1309316A2 (de) 2003-05-14
KR20030045035A (ko) 2003-06-09
IL154386A0 (en) 2003-09-17
NZ524123A (en) 2005-02-25
JP2004512274A (ja) 2004-04-22
WO2002015885A2 (en) 2002-02-28
US20020049233A1 (en) 2002-04-25
NZ524115A (en) 2004-10-29
DK1355631T3 (da) 2008-02-04
NO20030727L (no) 2003-03-24
AU2001286533A1 (en) 2002-03-04
WO2002015885A3 (en) 2003-08-28

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8327 Change in the person/name/address of the patent owner

Owner name: ASTELLAS PHARMA TECHNOLOGIES,INC. (N.D.GES.D.S, US

Owner name: PHARMACIA CORP., NORTH PEAPACK, N.J., US

8364 No opposition during term of opposition
8339 Ceased/non-payment of the annual fee