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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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320 rows where docket_id = "FDA-1995-S-0039" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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 75-Day Premarket Notifications for New Dietary Ingredients 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

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