RU2016142819A - Твердая композиция, содержащая аморфный софосбувир - Google Patents
Твердая композиция, содержащая аморфный софосбувир Download PDFInfo
- Publication number
- RU2016142819A RU2016142819A RU2016142819A RU2016142819A RU2016142819A RU 2016142819 A RU2016142819 A RU 2016142819A RU 2016142819 A RU2016142819 A RU 2016142819A RU 2016142819 A RU2016142819 A RU 2016142819A RU 2016142819 A RU2016142819 A RU 2016142819A
- Authority
- RU
- Russia
- Prior art keywords
- sofosbuvir
- solid composition
- chemical compound
- paragraphs
- composition according
- Prior art date
Links
- 239000008247 solid mixture Substances 0.000 title claims 28
- TTZHDVOVKQGIBA-IQWMDFIBSA-N sofosbuvir Chemical compound N1([C@@H]2O[C@@H]([C@H]([C@]2(F)C)O)CO[P@@](=O)(N[C@@H](C)C(=O)OC(C)C)OC=2C=CC=CC=2)C=CC(=O)NC1=O TTZHDVOVKQGIBA-IQWMDFIBSA-N 0.000 claims 40
- 229960002063 sofosbuvir Drugs 0.000 claims 40
- 150000001875 compounds Chemical class 0.000 claims 26
- 239000011159 matrix material Substances 0.000 claims 25
- 238000000034 method Methods 0.000 claims 23
- 239000002904 solvent Substances 0.000 claims 10
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 8
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 claims 8
- 239000003463 adsorbent Substances 0.000 claims 8
- 229910052710 silicon Inorganic materials 0.000 claims 8
- 239000010703 silicon Substances 0.000 claims 8
- 229920003169 water-soluble polymer Polymers 0.000 claims 8
- 238000001035 drying Methods 0.000 claims 6
- 239000000203 mixture Substances 0.000 claims 6
- 239000008194 pharmaceutical composition Substances 0.000 claims 6
- 238000001179 sorption measurement Methods 0.000 claims 6
- 150000001298 alcohols Chemical class 0.000 claims 5
- 150000002576 ketones Chemical class 0.000 claims 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 5
- 150000002148 esters Chemical class 0.000 claims 4
- 150000002170 ethers Chemical class 0.000 claims 4
- 150000008282 halocarbons Chemical class 0.000 claims 4
- 239000007787 solid Substances 0.000 claims 4
- 238000001694 spray drying Methods 0.000 claims 4
- 238000003795 desorption Methods 0.000 claims 3
- 239000006185 dispersion Substances 0.000 claims 3
- 238000002844 melting Methods 0.000 claims 3
- 230000008018 melting Effects 0.000 claims 3
- 239000000377 silicon dioxide Substances 0.000 claims 3
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 2
- 238000002159 adsorption--desorption isotherm Methods 0.000 claims 2
- 229910052784 alkaline earth metal Inorganic materials 0.000 claims 2
- 150000001342 alkaline earth metals Chemical class 0.000 claims 2
- 229920002678 cellulose Polymers 0.000 claims 2
- 235000010980 cellulose Nutrition 0.000 claims 2
- 238000004108 freeze drying Methods 0.000 claims 2
- 238000009474 hot melt extrusion Methods 0.000 claims 2
- 239000012943 hotmelt Substances 0.000 claims 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 239000006186 oral dosage form Substances 0.000 claims 2
- 239000003960 organic solvent Substances 0.000 claims 2
- 150000004760 silicates Chemical class 0.000 claims 2
- 235000012239 silicon dioxide Nutrition 0.000 claims 2
- 239000007962 solid dispersion Substances 0.000 claims 2
- 241000723347 Cinnamomum Species 0.000 claims 1
- 208000005176 Hepatitis C Diseases 0.000 claims 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims 1
- 229910052783 alkali metal Inorganic materials 0.000 claims 1
- 150000001340 alkali metals Chemical group 0.000 claims 1
- 229910000323 aluminium silicate Inorganic materials 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 235000017803 cinnamon Nutrition 0.000 claims 1
- 239000008119 colloidal silica Substances 0.000 claims 1
- 238000001704 evaporation Methods 0.000 claims 1
- 230000008020 evaporation Effects 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 238000005469 granulation Methods 0.000 claims 1
- 230000003179 granulation Effects 0.000 claims 1
- 238000010348 incorporation Methods 0.000 claims 1
- 229910052749 magnesium Inorganic materials 0.000 claims 1
- 239000011777 magnesium Substances 0.000 claims 1
- 238000002156 mixing Methods 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 claims 1
- 239000000741 silica gel Substances 0.000 claims 1
- 229910002027 silica gel Inorganic materials 0.000 claims 1
- 238000002336 sorption--desorption measurement Methods 0.000 claims 1
- 239000007921 spray Substances 0.000 claims 1
- 230000006641 stabilisation Effects 0.000 claims 1
- 238000011105 stabilization Methods 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000004094 surface-active agent Substances 0.000 claims 1
- 238000001291 vacuum drying Methods 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
- C07F9/06—Phosphorus compounds without P—C bonds
- C07F9/22—Amides of acids of phosphorus
- C07F9/222—Amides of phosphoric acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F9/00—Compounds containing elements of Groups 5 or 15 of the Periodic Table
- C07F9/02—Phosphorus compounds
- C07F9/547—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom
- C07F9/6558—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing at least two different or differently substituted hetero rings neither condensed among themselves nor condensed with a common carbocyclic ring or ring system
- C07F9/65586—Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing at least two different or differently substituted hetero rings neither condensed among themselves nor condensed with a common carbocyclic ring or ring system at least one of the hetero rings does not contain nitrogen as ring hetero atom
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
- C07H1/00—Processes for the preparation of sugar derivatives
- C07H1/06—Separation; Purification
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
- C07H19/00—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof
- C07H19/02—Compounds containing a hetero ring sharing one ring hetero atom with a saccharide radical; Nucleosides; Mononucleotides; Anhydro-derivatives thereof sharing nitrogen
- C07H19/04—Heterocyclic radicals containing only nitrogen atoms as ring hetero atom
- C07H19/06—Pyrimidine radicals
- C07H19/10—Pyrimidine radicals with the saccharide radical esterified by phosphoric or polyphosphoric acids
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Molecular Biology (AREA)
- Epidemiology (AREA)
- Biochemistry (AREA)
- Genetics & Genomics (AREA)
- Biotechnology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Virology (AREA)
- Oncology (AREA)
- Gastroenterology & Hepatology (AREA)
- Communicable Diseases (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14163434.5 | 2014-04-03 | ||
| EP14163434 | 2014-04-03 | ||
| PCT/EP2015/057411 WO2015150561A2 (en) | 2014-04-03 | 2015-04-02 | Solid composition comprising amorphous sofosbuvir |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2016142819A true RU2016142819A (ru) | 2018-05-10 |
| RU2016142819A3 RU2016142819A3 (enExample) | 2018-05-10 |
Family
ID=50397065
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2016142819A RU2016142819A (ru) | 2014-04-03 | 2015-04-02 | Твердая композиция, содержащая аморфный софосбувир |
Country Status (10)
| Country | Link |
|---|---|
| US (2) | US10493089B2 (enExample) |
| EP (1) | EP3125868A2 (enExample) |
| JP (1) | JP2017512811A (enExample) |
| KR (1) | KR20160142342A (enExample) |
| CN (1) | CN106163529A (enExample) |
| AU (1) | AU2015239018A1 (enExample) |
| CA (1) | CA2943574A1 (enExample) |
| MX (2) | MX2016012934A (enExample) |
| RU (1) | RU2016142819A (enExample) |
| WO (1) | WO2015150561A2 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10214553B2 (en) | 2014-06-13 | 2019-02-26 | Teva Pharmaceuticals International Gmbh | Solid state forms of sofosbuvir |
| WO2016038542A2 (en) * | 2014-09-10 | 2016-03-17 | Mylan Laboratories Limited | Polymorphic forms of sofosbuvir |
| CZ2015443A3 (cs) * | 2015-06-26 | 2017-01-04 | Zentiva, K.S. | Farmaceutická formulace sofosbuviru |
| EP3359199A1 (en) * | 2015-10-07 | 2018-08-15 | Sandoz AG | Solid pharmaceutical composition comprising amorphous sofosbuvir |
| CZ2016257A3 (cs) * | 2016-05-05 | 2017-11-15 | Zentiva, K.S. | Amorfní forma sofosbuviru, způsob její přípravy a její stabilizace |
| CN106083963A (zh) * | 2016-06-08 | 2016-11-09 | 上海现代制药海门有限公司 | 一种索非布韦晶型6的制备方法 |
| BR112019002729A2 (pt) * | 2016-08-12 | 2019-05-14 | Sandoz Ag | composição farmacêutica sólida e processo para preparar uma composição farmacêutica sólida |
| CZ2016553A3 (cs) | 2016-09-09 | 2018-03-21 | Zentiva, K.S. | Pevná farmaceutická dávková forma obsahující sofosbuvir |
| WO2018078536A1 (en) | 2016-10-26 | 2018-05-03 | Lupin Limited | Stable solid dispersion of sofosbuvir and process for preparation thereof |
| CN108210509A (zh) * | 2016-12-13 | 2018-06-29 | 南京圣和药业股份有限公司 | 新的核苷氨基磷酸脂化合物的组合物及其制备方法 |
| RU2659693C1 (ru) * | 2017-06-30 | 2018-07-03 | Общество с ограниченной ответственностью "Изварино Фарма" | Фармацевтическая композиция, обладающая активностью против ВИЧ-инфекции |
| WO2019134971A1 (en) * | 2018-01-04 | 2019-07-11 | Sandoz Ag | Encapsulated particles comprising a pharmaceutically active ingredient |
| EP3862318A4 (en) | 2018-10-05 | 2022-06-15 | Fuji Chemical Industry Co., Ltd. | Porous silica particle composition |
| CN111040010A (zh) * | 2019-12-23 | 2020-04-21 | 上海红蓝医药科技有限公司 | 一种索非布韦中间体的合成方法 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ513964A (en) * | 1999-12-08 | 2004-01-30 | Pharmacia Corp | Solid-state form of celecoxib having enhanced bioavailability |
| CN1200262C (zh) | 2003-01-10 | 2005-05-04 | 清华大学 | 测量粉末吸附气体量的方法和设备 |
| WO2010017965A2 (en) | 2008-08-11 | 2010-02-18 | Merck Serono S.A. | SOLID LIPID MICROCAPSULES CONTAINING hGH |
| TWI598358B (zh) | 2009-05-20 | 2017-09-11 | 基利法瑪席特有限責任公司 | 核苷磷醯胺 |
| JP2013527145A (ja) | 2010-03-31 | 2013-06-27 | ギリード・ファーマセット・エルエルシー | リン含有活性化剤の立体選択的合成 |
| EP2907505A3 (en) * | 2011-12-29 | 2015-12-30 | Abbvie Inc. | Solid compositions comprising an HCV inhibitor |
| BR112014016319A8 (pt) * | 2011-12-30 | 2017-07-04 | Chevron Usa Inc | processo, método, e sistema para remover metais pesados de fluidos |
| EP3650014B1 (en) * | 2013-08-27 | 2021-10-06 | Gilead Pharmasset LLC | Combination formulation of two antiviral compounds |
-
2015
- 2015-04-02 CN CN201580018422.4A patent/CN106163529A/zh not_active Withdrawn
- 2015-04-02 AU AU2015239018A patent/AU2015239018A1/en not_active Abandoned
- 2015-04-02 RU RU2016142819A patent/RU2016142819A/ru not_active Application Discontinuation
- 2015-04-02 US US15/129,149 patent/US10493089B2/en not_active Expired - Fee Related
- 2015-04-02 EP EP15713526.0A patent/EP3125868A2/en not_active Withdrawn
- 2015-04-02 WO PCT/EP2015/057411 patent/WO2015150561A2/en not_active Ceased
- 2015-04-02 JP JP2016560461A patent/JP2017512811A/ja not_active Ceased
- 2015-04-02 MX MX2016012934A patent/MX2016012934A/es unknown
- 2015-04-02 CA CA2943574A patent/CA2943574A1/en not_active Abandoned
- 2015-04-02 KR KR1020167030432A patent/KR20160142342A/ko not_active Withdrawn
-
2016
- 2016-09-30 MX MX2019009842A patent/MX2019009842A/es unknown
-
2019
- 2019-08-23 US US16/550,057 patent/US20190381085A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO2015150561A3 (en) | 2016-01-28 |
| MX2016012934A (es) | 2016-12-07 |
| US10493089B2 (en) | 2019-12-03 |
| EP3125868A2 (en) | 2017-02-08 |
| MX2019009842A (es) | 2019-10-22 |
| US20170100422A1 (en) | 2017-04-13 |
| US20190381085A1 (en) | 2019-12-19 |
| KR20160142342A (ko) | 2016-12-12 |
| CN106163529A (zh) | 2016-11-23 |
| JP2017512811A (ja) | 2017-05-25 |
| AU2015239018A1 (en) | 2016-10-13 |
| RU2016142819A3 (enExample) | 2018-05-10 |
| WO2015150561A2 (en) | 2015-10-08 |
| CA2943574A1 (en) | 2015-10-08 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FA92 | Acknowledgement of application withdrawn (lack of supplementary materials submitted) |
Effective date: 20191212 |