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Papertech, Inc. 2015-1063A Initial Papertech, Inc. 2015-1063B Initial Partner's Choicemed Inc. 2015-1304 Initial Perfect Sight letter Philusa Corporation 2015-122A ...

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Published by , 2016-11-17 00:25:03

List of Approved CPRs - Food and Drug Administration

Papertech, Inc. 2015-1063A Initial Papertech, Inc. 2015-1063B Initial Partner's Choicemed Inc. 2015-1304 Initial Perfect Sight letter Philusa Corporation 2015-122A ...

List of Approved CPRs

13 May 2016

Company Control No. Remarks

Abbott Laboratories 2015-1484 Initial
Absolute Life M edical Systems, Inc. 2015-707 Initial
Absolute Life M edical Systems, Inc. 2015-486 Initial
Absolute Life M edical Systems, Inc. 2015-672 Initial
Absolute Life M edical Systems, Inc. 2015-673 Initial
Absolute Life M edical Systems, Inc. 2015-670 Initial
Absolute Life M edical Systems, Inc. 2015-485 Initial
Absolute Life M edical Systems, Inc. 2015-484 Initial
Altheamed Pharmaceuticals, Inc. 2015-1057 Initial
Ambica Int'l Trading Corp. RAR16-350 Initial
Asia Primera Kimika Inc. letter
Asianstar Trading Philippines 2012-2697 Initial
Asianstar Trading Philippines 2012-2692 AR
Asianstar Trading Philippines 2012-2695 AR
Asianstar Trading Philippines 2012-2666 AR
Aso Philippines Inc. R-2014-1124 Initial
BF M erren Pharmaceuticals RAR16-234 Renewal
BF M erren Pharmaceuticals RAR16-235 Renewal
Bone Fix M etal Craft 2015-885B Initial
Bone Fix M etal Craft 2015-885A Initial
Bonteq M edical Distribution Phil. Inc. 2015-636 Initial
Bonteq M edical Distribution Phil. Inc. 2015-634 Initial
Bridgemark M arketing IVDR-00125 Reissuance
AR
Care Products 2013-4067
w/condition
CDM M arketing Center R-2014-1444 Initial
Champion Biotech and Pharma Corp. letter
Champion Biotech and Pharma Corp. letter

Champion Biotech/Watsons Personal Care Store 2014-963 Renewal

Completesolution Pharmacy & General 2015-662 Initial

M erchandise 2015-908 Initial
Croma M edic, Inc. 2015-691 Turned Initial
Delex Pharma International, Inc. 2015-1297 Initial
Dentsply (Phils.) Inc. RAR15-752B Renewal
DHI Trading Corporation RAR15-752A Renewal
DHI Trading Corporation 2015-1436 Initial
Dubbel M edical Corporation 2015-1159 Initial
East Lane Corporation 2015-572B Initial
Eastern Rising Sun Int'l Co. 2015-572B Initial
Eastern Rising Sun Int'l Co. RAR15-951 Renewal
Endure M edical, Inc.
Ethical Pharma Inc./ M edical Center Trading RAM 15-697 Amendment

Corp RARI16-010 Extension
Eurolab Pacific International Corp 2015-902 Initial
Europ Continents Phils., Inc. 2015-1112 Initial
Exceldent Trading 2015-1110 Initial
Exceldent Trading

Page 1

Exceldent Trading 2015-1111 Initial w/condition
Fairbright Enterprises, Inc. 2015-1443 Initial w/condition
Galderma Phils., Inc. RAR15-1354 Renewal w/condition
Galderma Phils., Inc. RAR15-1352 Renewal
Galderma Phils., Inc. RAR15-1353 Renewal
Glavox Biotech Corporation letter
Globo Asiatico Enterprises, Inc. RAR15-1147 Renewal
HBI Diagnostika, Inc. 2014-939 Renewal
Hospira Phils., Inc. 2015-967 Initial
Hospira Phils., Inc. 2015-968 Initial
Instatech, Inc. RAR16-323 Renewal
Instatech, Inc. RAR16-324 Renewal
Instatech, Inc. 2015-886A Initial
Instatech, Inc. 2015-886B Initial
Instatech, Inc. 2015-1163 Initial
International Pharmaceuticals, Inc. 2015-1558 Initial
Intersurgical Phils., Inc. 2015-919 Initial
Janissa Business Ventures, Inc. 2015-1308 Initial
Johnson & Johnson (Phils.) Inc. 2014-2587B Extension
Karihome Inc./Zuellig Pharma Corp. 2015-1064A Initial
Karihome Inc./Zuellig Pharma Corp. 2015-1064B Initial
Karihome Inc./Zuellig Pharma Corp. 2015-1064C Initial
Karihome Inc./Zuellig Pharma Corp. 2015-1064D Initial
Labmate Pharma Inc. 2013-3961 Initial
Lefort M edical Trading Corp. RAR15-939D Renewal
Lefort M edical Trading Corp. RAR15-939C Renewal
Lefort M edical Trading Corp. RAR15-939B Renewal
Lefort M edical Trading Corp. RAR15-939A Renewal
M acare M edicals, Inc 2015-931 Initial
M arsman Drysdale M edical Products, Inc. 2015-004A Initial
M arsman Drysdale M edical Products, Inc. 2014-2489B Correction
M arsman Drysdale M edical Products, Inc. 2014-2789A Correction
M edical Center Trading Corp 11DGT/I-8/2014-2622 Extension
M edic-Pro Corp. 2015-932A Initial
M edic-Pro Corp. 2015-932B Initial
M edic-Pro Corp. 2015-1175 Initial
M edlink M arketing RAR15-324 Renewal
M edtronic Philippines, Inc. RAR16-306B Renewal
M edtronic Philippines, Inc. RAR16-306A Renewal
M edtronic Philippines, Inc. RAR16-305 Renewal
M edtronic Philippines, Inc. RAR16-307 Renewal
M edtronix M edical Supplies & Equipment RAR16-308 Renewal
M etphil M edica letter
Neurospine Technology Trading Corporation 2015-833 Initial
OM M Healthcare Philippines Corporation RAR15-783 Renewal
Optimum Trading 2015-541 Initial
Orthopaedic International, Inc. 2015-1233 Initial
Orthopaedic International, Inc. 2015-464 Initial
Otsuka Phils. Pharmaceutical, Inc. RAR16-383 Renewal
Pacific Healthcare Phils., Inc./Phil. Shinpoong
RAM 15-683 Amendment
Pharma
Papertech, Inc. 2015-913 Initial

Page 2

Papertech, Inc. 2015-1063A Initial
Papertech, Inc. 2015-1063B Initial
Partner's Choicemed Inc. 2015-1304 Initial
Perfect Sight letter
Philusa Corporation 2015-122A Initial
Philusa Corporation 2015-122B Initial
Philusa Corporation 2015-122C Initial
Philusa Corporation 2015-122D Initial
Philusa Corporation RAR15-1083 Renewal
RBGM M edical Express Sales, Inc. 2015-1333B Initial
RBGM M edical Express Sales, Inc. 2015-1333A Initial
Rebmann, Inc. RAR16-384 Renewal
RM G Hospital Supply, Inc. 2015-1500 Initial
Security and Forensic Enterprises, Inc. RAR14-290 Renewal
Serodiagnostic Trading RARI16-011 Extension
Seville Pharmaceuticals, inc. 2015-943 Initial
Sinawal M edical Supplies 2015-1017 Initial
Sinawal M edical Supplies 2015-1019 Initial
Sinawal M edical Supplies 2015-1018 Initial
Sinawal M edical Supplies 2015-899 Initial
Sinawal M edical Supplies 2015-1016 Initial
Sinawal M edical Supplies 2015-976 Initial
Sinawal M edical Supplies 2015-897 Initial
Sinawal M edical Supplies 2015-811 Initial
Sinawal M edical Supplies 2015-871 Initial
Sinawal M edical Supplies 2015-814 Initial
Sinawal M edical Supplies 2015-940 Initial
Sinawal M edical Supplies 2015-900 Initial
Sinawal M edical Supplies 2015-868 Initial
Sinawal M edical Supplies 2015-867 Initial
Sinawal M edical Supplies 2015-974 Initial
Sinawal M edical Supplies 2015-938 Initial
Sinawal M edical Supplies 2015-939 Initial
Sinawal M edical Supplies 2015-901 Initial
Sinawal M edical Supplies 2015-941 Initial
Sinawal M edical Supplies 2015-812 Initial
Sinawal M edical Supplies 2015-942 Initial
Sinawal M edical Supplies 2015-977 Initial
Sinawal M edical Supplies 2015-973 Initial
Sinawal M edical Supplies 2015-975 Initial
Sinawal M edical Supplies 2015-898 Initial
Sinawal M edical Supplies 2015-870 Initial
Sinawal M edical Supplies 2015-813 Initial
Sinawal M edical Supplies 2015-869 Initial
Sinawal M edical Supplies 2015-810 Initial
South East Star Enterprises 2015-1526 Initial
South East Star Enterprises 2015-1528 Initial
South East Star Enterprises 2015-1529 Initial
South East Star Enterprises 2015-1527 Initial
St. Tyke, Inc. 2015-738 Correction
St. Tyke, Inc. 2015-737 Correction
St. Tyke, Inc. 2015-740 Correction

Page 3

Stangen Pharmaceutical Phils., Inc. 2015-582 Initial
Stangen Pharmaceutical Phils., Inc. 2015-583 Initial
Stangen Pharmaceutical Phils., Inc. 2015-581 Initial
Summa Tritech, Inc. 2015-334 Initial
Surgicare Corporation 2015-1246 Initial
Surgicom Trading Corporation 2015-1226 Initial
Surgikleene, Inc. 2015-1244 Initial
Sysmex Phils. Inc. RARI16-013 Extension
Sysmex Phils. Inc. RARI16-012 Extension
Terumo M arketing Philippines, Inc. 2015-736A Initial
Terumo M arketing Philippines, Inc. 2015-736B Initial
Terumo M arketing Philippines, Inc. 2015-736C Initial
Terumo M arketing Philippines, Inc. 2015-736D Initial
Terumo M arketing Philippines, Inc. 2015-1577A Initial
Terumo M arketing Philippines, Inc. 2015-1577B Initial
Terumo M arketing Philippines, Inc. RAR15-1123 Renewal
The Pharmedic Corporation RAR16-344 Renewal
Ti-Tech M edical Trading 2015-1142A Initial
Ti-Tech M edical Trading 2015-1142B Initial
Ti-Tech M edical Trading 2015-1142C Initial
Ti-Tech M edical Trading 2015-1142D Initial
Ti-Tech M edical Trading 2015-4060A Initial
Ti-Tech M edical Trading 2015-4060B Initial
Ti-Tech M edical Trading 2015-806A Initial
Ti-Tech M edical Trading 2015-806B Initial
Ti-Tech M edical Trading 2015-1222A Initial
Ti-Tech M edical Trading 2015-1222B Initial
Value-Rx, inc. 2015-1429 Initial
Value-Rx, inc. RAR16-368 Renewal
Watsons Personal Care Sore (Phils) Inc./Bhagi's
RAR15-1196 Extension
Int
Wellness PRO Incorporated letter

Page 4


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