id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-1995-S-0039-0321,FDA,FDA-1995-S-0039,"Attachment 1 - Shah, et al., An Open Clinical Pilot Study to Evaluate the Safety and Efficacy of Natto Kinaseas an Add-on Oral Fibrinolytic Agent Tolow Molecular Weight Heparin & Anti-Plateletsin Acute Ischeamic Stroke"" re NDI 631, Nattolife/Nattokinase Enzyme from Zytech Biotech PVT LTD",Supporting & Related Material,Background Material,2014-02-28T05:00:00Z,2014,2,,,2016-08-15T20:52:33Z,,0,0,0900006480c36026 FDA-1995-S-0039-0309,FDA,FDA-1995-S-0039,"NDI 674, Conifer Green Needle Complex CGNC from Solagran",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:47Z,,0,0,0900006480ec536b FDA-1995-S-0039-0312,FDA,FDA-1995-S-0039,"NDI 679, DHA-EPA Algal Oil from Martek Biosciences Corporation",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:50Z,,0,0,0900006480ec8b58 FDA-1995-S-0039-0311,FDA,FDA-1995-S-0039,NDI 677 Amizate from Zymetch,Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:49Z,,0,0,0900006480ec5aa6 FDA-1995-S-0039-0310,FDA,FDA-1995-S-0039,"NDI 675, Sun Chlorella Agaricus from Sun Chlorella",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:48Z,,0,0,0900006480ec53ea FDA-1995-S-0039-0313,FDA,FDA-1995-S-0039,Report 680 Hitex SAS (Miliaskin),Other,Report,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:50Z,,0,0,0900006480ec8b68 FDA-1995-S-0039-0315,FDA,FDA-1995-S-0039,"NDI 715, Ajuga Reptans Cell Culture Extracts from RB Istituto di Ricerche Biotecnologiche S.p.A",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:54Z,,0,0,0900006480fa1816 FDA-1995-S-0039-0314,FDA,FDA-1995-S-0039,"NDI 681, Benfotiamine from Yonezawa Hamari Chemicals, Ltd",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:54Z,,0,0,0900006480ec8b89 FDA-1995-S-0039-0317,FDA,FDA-1995-S-0039,"Attachments - Healthcare Professional Tab, Reseveratol re NDI 583, Resveratrol from Ceres Living, Inc.",Supporting & Related Material,Background Material,2014-02-27T05:00:00Z,2014,2,,,2016-09-30T14:24:57Z,,0,0,0900006480ae77c3 FDA-1995-S-0039-0319,FDA,FDA-1995-S-0039,"NDI 671, 7-Methylxanthine from AVEC Eye Center, LLC",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:25:00Z,,0,0,0900006480c47768 FDA-1995-S-0039-0316,FDA,FDA-1995-S-0039,"NDI 716, GD Antrodia Camphorata from Golden Biotechnology Corporation",Other,75 Day PreMarket Notification,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:56Z,,0,0,0900006480fa1db0 FDA-1995-S-0039-0318,FDA,FDA-1995-S-0039,NDI 639 - Lumi Vida from DSM Food Specialities,Other,Report,2014-02-27T05:00:00Z,2014,2,2014-02-27T05:00:00Z,,2016-09-30T14:24:57Z,,0,0,0900006480b0e792 FDA-1995-S-0039-0308,FDA,FDA-1995-S-0039,FDA/CFSAN Response to General Nutrition Corporation - Supplement,Other,Supplement (SUP),2013-10-18T04:00:00Z,2013,10,2013-10-18T04:00:00Z,,2016-09-30T14:24:47Z,,0,0,090000648055c502 FDA-1995-S-0039-0304,FDA,FDA-1995-S-0039,Report from FDA/CFSAN,Other,Report,2012-09-23T04:00:00Z,2012,9,2012-09-23T04:00:00Z,,2016-09-30T14:24:45Z,,0,0,090000648055c329 FDA-1995-S-0039-0299,FDA,FDA-1995-S-0039,Report from FDA/CFSAN,Other,Report,2012-09-23T04:00:00Z,2012,9,2012-09-23T04:00:00Z,,2016-09-30T14:24:43Z,,0,0,090000648055c312 FDA-1995-S-0039-0307,FDA,FDA-1995-S-0039,"Attachment ""References"" Report from FDA/CFSAN",Supporting & Related Material,Report,2012-09-23T04:00:00Z,2012,9,,,2016-09-30T14:24:46Z,,0,0,090000648055c33a FDA-1995-S-0039-0296,FDA,FDA-1995-S-0039,"References 1 through 16 re NDI 589, 3b Androsterone from Proprietary Wellness",Supporting & Related Material,Background Material,2012-07-23T04:00:00Z,2012,7,,,2016-09-30T14:24:40Z,,0,0,0900006480a3efbc FDA-1995-S-0039-0298,FDA,FDA-1995-S-0039,Mitsibushi Gas Chemical Company (Pyrroloquinoline Quinone Disodium Salt) Report 417 - Amended Report re FDA-1995-S-0039-0141,Other,Amendment,2012-07-23T04:00:00Z,2012,7,,,2016-09-30T14:24:43Z,,0,0,09000064807649bd FDA-1995-S-0039-0297,FDA,FDA-1995-S-0039,Mitsibushi Gas Chemical Company (Pyrroloquinoline Quinone Disodium Salt) Report 417 - Report,Other,Report,2012-07-23T04:00:00Z,2012,7,2012-07-23T04:00:00Z,,2016-09-30T14:24:42Z,,0,0,0900006480560f26 FDA-1995-S-0039-0293,FDA,FDA-1995-S-0039,"NDI 636, Extrafolate [6(R,S)-5-Methyltetrahydrofolic Acid, Calcium Salt from Gnosis S.P.A.",Other,75 Day PreMarket Notification,2012-07-19T04:00:00Z,2012,7,,,2016-09-30T14:24:35Z,,0,0,0900006480b0bc32 FDA-1995-S-0039-0295,FDA,FDA-1995-S-0039,"NDI 638, Marine Aminos of Pink Murex [Phyllonotus Erythrostomus] from Gold Leaf Sustainable",Other,75 Day PreMarket Notification,2012-07-19T04:00:00Z,2012,7,2012-07-19T04:00:00Z,,2016-09-30T14:24:39Z,,0,0,0900006480b0e705 FDA-1995-S-0039-0294,FDA,FDA-1995-S-0039,"NDI 637, Extrafolate-S [6(S)-5-Methyltetrahydrofolic Acid, Calcium Salt] from Gnosis S.p.A.",Other,75 Day PreMarket Notification,2012-07-19T04:00:00Z,2012,7,,,2016-09-30T14:24:37Z,,0,0,0900006480b0cae1 FDA-1995-S-0039-0292,FDA,FDA-1995-S-0039,"NDI 635, Geranti Bio-Ge Yeast from Gerenti Pharm Ltd",Other,75 Day PreMarket Notification,2012-03-23T04:00:00Z,2012,3,2012-03-23T04:00:00Z,,2016-09-30T14:24:34Z,,0,0,0900006480b0bab3 FDA-1995-S-0039-0290,FDA,FDA-1995-S-0039,"NDI 632, Puresta Oil from YamahaMotor Co., LTD",Other,Report,2012-03-23T04:00:00Z,2012,3,2012-03-23T04:00:00Z,,2016-09-30T14:24:33Z,,0,0,0900006480b0a55d FDA-1995-S-0039-0291,FDA,FDA-1995-S-0039,"NDI 634, Horse Bone Extract from Branch Corporation Finance-Investment-Construction",Other,75 Day PreMarket Notification,2012-03-23T04:00:00Z,2012,3,2012-03-23T04:00:00Z,,2016-09-30T14:24:33Z,,0,0,0900006480b0b8dd FDA-1995-S-0039-0288,FDA,FDA-1995-S-0039,"Report 394 Amendment NDI 444 PHX Partners, LLC (Formerly PHX Health Solutions, Inc.)",Other,Report,2012-03-22T04:00:00Z,2012,3,2012-03-22T04:00:00Z,,2016-09-30T14:24:32Z,,0,0,09000064805609b6 FDA-1995-S-0039-0287,FDA,FDA-1995-S-0039,"Report 393 Amendment NDI 443 PHX Partners, LLC (Formerly PHX Health Solutions, Inc.)",Other,Report,2012-03-22T04:00:00Z,2012,3,2012-03-22T04:00:00Z,,2016-09-30T14:24:31Z,,0,0,09000064805609b3 FDA-1995-S-0039-0289,FDA,FDA-1995-S-0039,"Report 395 Amendment NDI 445 PHX Partners, LLC (Formerly PHX Health Solutions, Inc.)",Other,Report,2012-03-22T04:00:00Z,2012,3,2012-03-22T04:00:00Z,,2016-09-30T14:24:32Z,,0,0,09000064805609b8 FDA-1995-S-0039-0286,FDA,FDA-1995-S-0039,"NDI 631, Nattolife/Nattokinase Enzyme from Zytech Biotech PVT LTD",Other,75 Day PreMarket Notification,2012-03-19T04:00:00Z,2012,3,2012-03-19T04:00:00Z,,2016-09-30T14:24:30Z,,0,0,0900006480c36025 FDA-1995-S-0039-0278,FDA,FDA-1995-S-0039,"NDI 618, Sea Buckthorn Berry Juice from Meaningful Food Company",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:20Z,,0,0,0900006480fcefc4 FDA-1995-S-0039-0280,FDA,FDA-1995-S-0039,"NDI 623, Riboceine D-Ribose-L-Cysteine from Max International, LLC.",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:25Z,,0,0,0900006480c08317 FDA-1995-S-0039-0281,FDA,FDA-1995-S-0039,"NDI 624, Hydrolyzed Lignin from AVVA Pharmaceuticals AG",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2018-11-30T20:28:08Z,,0,0,0900006480c1afd8 FDA-1995-S-0039-0284,FDA,FDA-1995-S-0039,"NDI 629, Fulvic Acid from Miyamonte U.S.A., Inc",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:29Z,,0,0,0900006480c1b0d5 FDA-1995-S-0039-0283,FDA,FDA-1995-S-0039,"NDI 626, Lipowheat Oil from Hitex SAS",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:28Z,,0,0,0900006480c1b0b6 FDA-1995-S-0039-0282,FDA,FDA-1995-S-0039,"NDI 625, Obestilin from Sabinsa Corporation",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:28Z,,0,0,0900006480c1b04e FDA-1995-S-0039-0285,FDA,FDA-1995-S-0039,"NDI 630, Mulberry Leaf Powder from Ray Farm Corporation",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:29Z,,0,0,0900006480c1b0d6 FDA-1995-S-0039-0279,FDA,FDA-1995-S-0039,"NDI 621, Fernblock from Industrial Farmaceutica Cantabria, S.A.",Other,75 Day PreMarket Notification,2012-03-05T05:00:00Z,2012,3,2012-03-05T05:00:00Z,,2016-09-30T14:24:24Z,,0,0,0900006480c08a3a FDA-1995-S-0039-0275,FDA,FDA-1995-S-0039,Report 614 - Capterin from SanRx Pharmaceuticals re NDI 611,Other,75 Day PreMarket Notification,2012-03-02T05:00:00Z,2012,3,2012-03-02T05:00:00Z,,2016-09-30T14:24:10Z,,0,0,0900006480ab7e4d FDA-1995-S-0039-0276,FDA,FDA-1995-S-0039,"NDI 615, Calcium Formate from Nephro Tech LLC",Other,75 Day PreMarket Notification,2012-03-02T05:00:00Z,2012,3,2012-03-02T05:00:00Z,,2016-09-30T14:24:15Z,,0,0,0900006480ab88b7 FDA-1995-S-0039-0277,FDA,FDA-1995-S-0039,"NDI 616, Antrodia Cinnamomea from MoTech Corporation",Other,75 Day PreMarket Notification,2012-03-02T05:00:00Z,2012,3,2012-03-02T05:00:00Z,,2016-09-30T14:24:19Z,,0,0,0900006480af05ab FDA-1995-S-0039-0272,FDA,FDA-1995-S-0039,"NDI 610 - AsrraGrin from Nuliv Science USA, Inc.",Other,75 Day PreMarket Notification,2012-01-23T05:00:00Z,2012,1,2012-01-23T05:00:00Z,,2016-09-30T14:24:02Z,,0,0,0900006480aad124 FDA-1995-S-0039-0271,FDA,FDA-1995-S-0039,"NDI 609 - Sonova 400 from Arcadia Biosciences, Inc.",Other,75 Day PreMarket Notification,2012-01-23T05:00:00Z,2012,1,2012-01-23T05:00:00Z,,2016-09-30T14:24:00Z,,0,0,0900006480aa9eaa FDA-1995-S-0039-0274,FDA,FDA-1995-S-0039,"NDI 613, SelenoForce from Sabinsa Corporation",Other,75 Day PreMarket Notification,2012-01-23T05:00:00Z,2012,1,2012-01-23T05:00:00Z,,2016-09-30T14:24:04Z,,0,0,0900006480ab317a FDA-1995-S-0039-0273,FDA,FDA-1995-S-0039,"NDI 612, Cissus Quadrangularis from Gateway Health Alliances, Inc.",Other,75 Day PreMarket Notification,2012-01-23T05:00:00Z,2012,1,2012-01-23T05:00:00Z,,2016-09-30T14:24:02Z,,0,0,0900006480aad125 FDA-1995-S-0039-0265,FDA,FDA-1995-S-0039,"Attachment X -Joh et al, Clinical Result of the Intestinal Remedy (Biothree(r) Containing Three Live Bacteria Species for Bacterial Diarhea, Progress in Medicine Vol.13 (1983) re NDI 603, Bio-Three H Powder from Josifa International, Inc.",Supporting & Related Material,Background Material,2012-01-18T05:00:00Z,2012,1,,,2016-08-15T18:54:23Z,,0,0,0900006480f990d0 FDA-1995-S-0039-0267,FDA,FDA-1995-S-0039,"NDI 606, Triclisia subcordata Oliv., Anuolu from Cornelius Babsanya-Craig",Other,75 Day PreMarket Notification,2012-01-18T05:00:00Z,2012,1,2012-01-18T05:00:00Z,,2016-09-30T14:23:58Z,,0,0,0900006480aa9a26 FDA-1995-S-0039-0269,FDA,FDA-1995-S-0039,"Literature and References, Exhibits V-Z re NDI 607- NDI 584 Amendment - Antistax Red Vine Leaf Extract from Boehringer Ingelhheim Pharmaceuticals, Inc.",Supporting & Related Material,Background Material,2012-01-18T05:00:00Z,2012,1,,,2016-08-15T20:05:35Z,,0,0,0900006480aa9bff FDA-1995-S-0039-0264,FDA,FDA-1995-S-0039,"NDI 591, D-Ribose-L-Cysteine, Riboceine from Max International, LLC,",Other,75 Day PreMarket Notification,2012-01-18T05:00:00Z,2012,1,2012-01-18T05:00:00Z,,2016-09-30T14:23:57Z,,0,0,0900006480a3f3c5 FDA-1995-S-0039-0266,FDA,FDA-1995-S-0039,"NDI 605, Sesame Peptide KM-20 from Uniglobe Kisco, Inc.",Other,75 Day PreMarket Notification,2012-01-18T05:00:00Z,2012,1,2012-01-18T05:00:00Z,,2016-09-30T14:23:58Z,,0,0,0900006480aa87e1 FDA-1995-S-0039-0270,FDA,FDA-1995-S-0039,"NDI 608 - Lactobacillus Paracasei GM080 from GenMont Biotech, Inc.",Other,75 Day PreMarket Notification,2012-01-18T05:00:00Z,2012,1,2012-01-18T05:00:00Z,,2016-09-30T14:23:59Z,,0,0,0900006480b08de1 FDA-1995-S-0039-0268,FDA,FDA-1995-S-0039,"NDI 607 NDI 584 Amendment - Boehringer Ingelhheim Pharmaceuticals, Inc. (Antistax Red Vine Leaf Extract)",Other,75 Day PreMarket Notification,2012-01-18T05:00:00Z,2012,1,2012-01-18T05:00:00Z,,2016-09-30T14:23:59Z,,0,0,0900006480aa9bcd FDA-1995-S-0039-0245,FDA,FDA-1995-S-0039,"References Cover Page - re NDI 587 - Androsta-1,4,6-triene-3,17-dione from Proprietary Wellness",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-09-30T14:23:43Z,,0,0,0900006480a2bd3e FDA-1995-S-0039-0255,FDA,FDA-1995-S-0039,"NDI 597, Milkweed Seed Oil (MSO) from Natural Fibers Corporation",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:52Z,,0,0,0900006480a59a3a FDA-1995-S-0039-0246,FDA,FDA-1995-S-0039,"NDI 592 - Androst-4-ene03,16,17-trione from Proprietary Wellness",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:47Z,,0,0,0900006480a408a1 FDA-1995-S-0039-0260,FDA,FDA-1995-S-0039,"NDI 603, Bio-Three H Powder from Josifa International, Inc.",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:55Z,,0,0,0900006480a91b4a FDA-1995-S-0039-0247,FDA,FDA-1995-S-0039,"Cited References - re NDI 592 - Androst-4-ene03,16,17-trione from Proprietary Wellness) (Part 1 of 3)",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-08-12T16:11:27Z,,0,0,0900006480a41168 FDA-1995-S-0039-0261,FDA,FDA-1995-S-0039,"Attachment V - Nomura, et al, Probiotics Reduce Infectious Complications After Pancreaticoduodenectomy, Hepato-Gastroenterology Vol.54 (2007) re NDI 603, Bio-Three H Powder from Josifa International, Inc.",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-08-15T18:49:26Z,,0,0,0900006480aa55d1 FDA-1995-S-0039-0254,FDA,FDA-1995-S-0039,"NDI 596, NDI 596, Homotaurine from Ovos Natural Health Inc from Ovos Natural Health Inc",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:51Z,,0,0,0900006480a7d6c8 FDA-1995-S-0039-0262,FDA,FDA-1995-S-0039,"NDI 604, Adrenosterone from Propietary Wellness",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:56Z,,0,0,0900006480aa6855 FDA-1995-S-0039-0253,FDA,FDA-1995-S-0039,"Reference 1 - Hall et al, Recent Progress in the Consideration of Flavoring Ingredients Under the Food Additives Amendment, III. GRAS Substances re NDI 595 - Linalool Oil from Hanader Corporation",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-08-12T21:06:05Z,,0,0,0900006480a526bd FDA-1995-S-0039-0256,FDA,FDA-1995-S-0039,"NDI 598, Aka-shoma Extract Powder from BHN Co., Ltd",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:52Z,,0,0,0900006480a59a3b FDA-1995-S-0039-0259,FDA,FDA-1995-S-0039,"NDI 602, Femblock from Industrial Farmaceutica Cantabria, S.A",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:54Z,,0,0,0900006480a913ba FDA-1995-S-0039-0258,FDA,FDA-1995-S-0039,"NDI 600, Corbicula Fluminea from Motech Corporation",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:54Z,,0,0,0900006480a8e405 FDA-1995-S-0039-0250,FDA,FDA-1995-S-0039,"Amendment re NDI 594 - AlgaeCal from AlgaeCal, Inc.",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:49Z,,0,0,0900006480a51ea1 FDA-1995-S-0039-0263,FDA,FDA-1995-S-0039,"Attachment 1 - Mayer et al., Seasonal Changes in and Effect of Castration/Androgen Replacement on the Plasma Levels of Five Androgens in the Male Three-Spined Stickleback, Gasterosteus Aculeatus L, General And Comparative Endocrinology Vol.17 (1990) re NDI 604 - Adrenosterone from Propietary Wellness",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-08-12T20:10:57Z,,0,0,0900006480aa6965 FDA-1995-S-0039-0252,FDA,FDA-1995-S-0039,NDI 595 - Linalool Oil from Hanader Corporation,Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:51Z,,0,0,0900006480a526bc FDA-1995-S-0039-0251,FDA,FDA-1995-S-0039,"Attachment 3 - Adey, et al., Phymatolithon Calcareum (Pallas) - re Amendment NDI 594 - AlgaeCal from AlgaeCal, Inc.",Supporting & Related Material,Background Material,2012-01-17T05:00:00Z,2012,1,,,2016-08-12T21:02:52Z,,0,0,0900006480a52075 FDA-1995-S-0039-0257,FDA,FDA-1995-S-0039,"NDI 599, Niu Zhang Zhi Mycelia Powder, Essence of Antrodia Cinnamomea Capsules from Motech Corporation",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:53Z,,0,0,0900006480a59c58 FDA-1995-S-0039-0249,FDA,FDA-1995-S-0039,"NDI 594 - AlgaeCal from AlgaeCal, Inc.",Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:48Z,,0,0,0900006480a51ea0 FDA-1995-S-0039-0248,FDA,FDA-1995-S-0039,NDI 593 - Solubilized Eggshell Membrane from Biova LLC,Other,75 Day PreMarket Notification,2012-01-17T05:00:00Z,2012,1,2012-01-17T05:00:00Z,,2016-09-30T14:23:48Z,,0,0,0900006480a51e9f FDA-1995-S-0039-0242,FDA,FDA-1995-S-0039,Exhibit B - Reference -1 re NDI 590 - (Diosmin) Exhibits A and B from Exquim S.A.,Supporting & Related Material,Background Material,2012-01-12T05:00:00Z,2012,1,,,2016-09-21T20:54:34Z,,0,0,0900006480a7cac8 FDA-1995-S-0039-0243,FDA,FDA-1995-S-0039,Exhibit C Cited References 1 - 7 re NDI 590 - (Diosmin) Exhibits A and B from Exquim S.A.,Supporting & Related Material,Background Material,2012-01-12T05:00:00Z,2012,1,,,2016-08-11T19:54:38Z,,0,0,0900006480a7cb53 FDA-1995-S-0039-0244,FDA,FDA-1995-S-0039,"Exhibit C - Reference 8 - Evaluation of the Health Aspects of Hesperidin, Naringin, and Citrus Bioflavonoid Extracts as Food Ingredients re Exhibit C Cited References 1 - 7 re NDI 590 - (Diosmin) Exhibits A and B from Exquim S.A.",Supporting & Related Material,Background Material,2012-01-12T05:00:00Z,2012,1,,,2016-09-30T14:23:43Z,,0,0,0900006480a7d613 FDA-1995-S-0039-0241,FDA,FDA-1995-S-0039,NDI 590 - (Diosmin) Exhibits A and B from Exquim S.A.,Other,75 Day PreMarket Notification,2011-02-10T05:00:00Z,2011,2,2011-02-10T05:00:00Z,,2016-09-30T14:23:42Z,,0,0,0900006480a7ca0b FDA-1995-S-0039-0238,FDA,FDA-1995-S-0039,"Report 416 - T. J. Panorama, Inc., (Nucleic Acid Supplement Capsules, AMP, CMP, GMP,UMP, and RNA)",Other,RPT-Report,2010-10-06T04:00:00Z,2010,10,2010-10-06T04:00:00Z,,2016-09-30T14:23:41Z,,0,0,0900006480560f17 FDA-1995-S-0039-0239,FDA,FDA-1995-S-0039,"PanGenomics, Inc. (PG102, Actinidia Arguta) Report 164 - Report",Other,Report,2010-10-06T04:00:00Z,2010,10,2010-10-06T04:00:00Z,,2016-09-30T14:23:41Z,,0,0,090000648055ca0c FDA-1995-S-0039-0240,FDA,FDA-1995-S-0039,Report 214 - Perrigo Company (Isopropoxy Isoflavone [Ipriflavone]),Other,RPT-Report (outside of agency unless indicated),2010-10-06T04:00:00Z,2010,10,2010-10-06T04:00:00Z,,2016-09-30T14:23:42Z,,0,0,090000648055cd12 FDA-1995-S-0039-0237,FDA,FDA-1995-S-0039,"NDI 583, Resveratrol from Ceres Living, Inc.",Other,75 Day PreMarket Notification,2010-05-05T04:00:00Z,2010,5,2010-05-05T04:00:00Z,,2016-09-30T14:23:40Z,,0,0,0900006480ae77c1 FDA-1995-S-0039-0235,FDA,FDA-1995-S-0039,"NDI 588, 3a Androsterone from Proprietary Wellness",Other,75 Day PreMarket Notification,2010-03-01T05:00:00Z,2010,3,2010-03-01T05:00:00Z,,2016-09-30T14:23:39Z,,0,0,0900006480a30fd0 FDA-1995-S-0039-0236,FDA,FDA-1995-S-0039,"NDI 589, 3b Androsterone from Proprietary Wellness",Other,75 Day PreMarket Notification,2010-03-01T05:00:00Z,2010,3,,,2016-09-30T14:23:40Z,,0,0,0900006480a3efbb FDA-1995-S-0039-0234,FDA,FDA-1995-S-0039,"Letter from Onbix Corporation to FDA, October 21, 2008 re NDI 550 - NPL-X",Other,Letter(s),2010-01-10T05:00:00Z,2010,1,2010-01-10T05:00:00Z,,2016-09-30T14:23:39Z,,0,0,0900006480a7894b FDA-1995-S-0039-0227,FDA,FDA-1995-S-0039,"Appendix L - ""Toxicology Consultant's Report: Consultants Resume,"" (Darcy Perkins, Ph.D) - re NDI 586 - Oxaloacetic Acid from Terra Biological LLC",Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:37Z,,0,0,0900006480a2fdd3 FDA-1995-S-0039-0224,FDA,FDA-1995-S-0039,NDI 586 - Oxaloacetic Acid from Terra Biological LLC,Other,75 Day PreMarket Notification,2009-12-09T05:00:00Z,2009,12,2009-12-09T05:00:00Z,,2016-09-30T14:23:36Z,,0,0,0900006480a2eb6f FDA-1995-S-0039-0228,FDA,FDA-1995-S-0039,Appendix A/Attachment A-4 (Redacted) - re NDI 586 - Oxaloacetic Acid from Terra Biological LLC,Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:37Z,,0,0,0900006480a2ff1a FDA-1995-S-0039-0233,FDA,FDA-1995-S-0039,Letter from FDA/CFSAN to Shannon Minerals Ltd. re NDI 305 - Extract of Garcinia Cambogia (Burren Spring Trim),Other,Supplement (SUP),2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:38Z,,0,0,0900006480a6272c FDA-1995-S-0039-0230,FDA,FDA-1995-S-0039,"NDI 587 - Androsta-1,4,6-triene-3,17-dione from Proprietary Wellness",Other,75 Day PreMarket Notification,2009-12-09T05:00:00Z,2009,12,2009-12-09T05:00:00Z,,2016-09-30T14:23:37Z,,0,0,0900006480a2bc6d FDA-1995-S-0039-0232,FDA,FDA-1995-S-0039,Letter from FDA/CFSAN to Shannon Minerals Ltd. re NDI 304 - Extract of Garcinia Cambogia (Coolwater Trim),Other,Supplement (SUP),2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:38Z,,0,0,0900006480a6272b FDA-1995-S-0039-0226,FDA,FDA-1995-S-0039,Appendices E-J (Redacted in its Entirety) - re NDI 586 - Oxaloacetic Acid from Terra Biological LLC,Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:36Z,,0,0,0900006480a2fd96 FDA-1995-S-0039-0231,FDA,FDA-1995-S-0039,"Reference 34 - Demonstration of 1,4,6-Androstatriene-3,17-Dione (ATD, CAS Registry No.633-35-2) in the Urine of an Untreated Boar""References Cover Page - re References Cover Page re NDI 587 - Androsta-1,4,6-triene-3,17-dione from Proprietary Wellness",Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:38Z,,0,0,0900006480a2be1b FDA-1995-S-0039-0225,FDA,FDA-1995-S-0039,"Appendices A-C and Attachment A-1,2 (Redacted in it Entirety) - re NDI 586 - Oxaloacetic Acid from Terra Biological LLC.",Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:36Z,,0,0,0900006480a2eb71 FDA-1995-S-0039-0229,FDA,FDA-1995-S-0039,"Attachment 13 - ""Greer, et al, An AMPK-FOXO Pathway Mediates the Extension of Lifespan Included by a Novel Method of Dietary Restriction In C. Elegans"" - re NDI 586 - Oxaloacetic Acid from Terra Biological LLC",Supporting & Related Material,Background Material,2009-12-09T05:00:00Z,2009,12,,,2016-09-30T14:23:37Z,,0,0,0900006480a309f6 FDA-1995-S-0039-0223,FDA,FDA-1995-S-0039,NDI 585 - Blessed Seed from Nature Therapy Corporation,Other,75 Day PreMarket Notification,2009-12-08T05:00:00Z,2009,12,2009-12-08T05:00:00Z,,2016-09-30T14:23:36Z,,0,0,0900006480a2a0df FDA-1995-S-0039-0212,FDA,FDA-1995-S-0039,"Appendix A - ""Background and History of Use"" - [Report 304 - Shannon Minerals Ltd. - Extract of Garcinia Cambogia (Coolwater Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:32Z,,0,0,090000648055eebc FDA-1995-S-0039-0210,FDA,FDA-1995-S-0039,"Section 4 - ""History of Use/ Safety Evidence"" - [Report 304 - Shannon Minerals Ltd. - Extract of Garcinia Cambogia (Coolwater Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:31Z,,0,0,090000648055eee5 FDA-1995-S-0039-0221,FDA,FDA-1995-S-0039,"Section 4 - ""History of Use/Safety Evidence"" - [Report 305 - Shannon Minerals, Ltd. - Extract of Garcinia Cambogia (Burren Spring Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:34Z,,0,0,090000648055ef01 FDA-1995-S-0039-0213,FDA,FDA-1995-S-0039,"Appendix A - ""Lewis, et al., Research Paper; (-)-Hydroxycitric Acid The Principal Acid in the Fruits of Garcinia Cambogia Desr."" - [Report 304 - Shannon Minerals Ltd. - Extract of Garcinia Cambogia (Coolwater Trim 75 Day Pre-Market Notification)",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:32Z,,0,0,090000648055eedc FDA-1995-S-0039-0209,FDA,FDA-1995-S-0039,"Section 3 - ""Description of the Products Containg Extract of Garcinia Cambogia, (-)-HCA"" - [Report 304 - Shannon Minerals Ltd. - Extract of Garcinia Cambogia (Coolwater Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:31Z,,0,0,090000648055eeed FDA-1995-S-0039-0219,FDA,FDA-1995-S-0039,"Section 2 - ""Name and Identity of New Dietary Ingredient"" - [Report 305 - Shannon Minerals, Ltd. - Extract of Garcinia Cambogia (Burren Spring Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:34Z,,0,0,090000648055eefc FDA-1995-S-0039-0203,FDA,FDA-1995-S-0039,FDA/CFSAN Letter to Shannon Minerals Ltd - [Report 304 - Shannon Minerals Ltd. - Extract of Garcinia Cambogia (Coolwater Trim 75 Day Pre-Market Notification),Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:29Z,,0,0,090000648055eedf FDA-1995-S-0039-0220,FDA,FDA-1995-S-0039,"Section 3 - ""Description of the Products Containing Extract of Garcinia Cambogia, (-)-HCA"" - [Report 305 - Shannon Minerals, Ltd. - Extract of Garcinia Cambogia (Burren Spring Trim 75 Day Pre-Market Notification)]",Supporting & Related Material,RPT-Report (Supporting and Related Material),2009-12-04T05:00:00Z,2009,12,,,2016-09-30T14:23:34Z,,0,0,090000648055eeff