{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2012-S-1178\" sorted by posted_date descending", "rows": [["FDA-2012-S-1178-0194", "FDA", "FDA-2012-S-1178", "Reference List re NDI 774, Annex XV Dry Skin in Dematology: a complex physiopathology from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T12:32:38Z", null, 0, 0, "090000648186f057"], ["FDA-2012-S-1178-0195", "FDA", "FDA-2012-S-1178", "NDI 774 re Annex XVI Composition and Distribution of Individual Molecular Species of Major Glycolipids in Wheat Flour from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T12:33:59Z", null, 0, 0, "090000648186f058"], ["FDA-2012-S-1178-0185", "FDA", "FDA-2012-S-1178", "Annex VI Biotransformation Des Produits Cerealiers re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186f02f"], ["FDA-2012-S-1178-0193", "FDA", "FDA-2012-S-1178", "Reference List re NDI 774, Annex XIV Metabolism of Cerebrosidein the Intestinal Tract of the Rat from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T12:32:58Z", null, 0, 0, "090000648186f056"], ["FDA-2012-S-1178-0200", "FDA", "FDA-2012-S-1178", "Annex XXI Sphingolipids in Food and the Emerging Importance of Sphingolipids to Nutrition re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:57:19Z", null, 0, 0, "090000648186f05d"], ["FDA-2012-S-1178-0186", "FDA", "FDA-2012-S-1178", "Annex VII Ceramides and the stratum corneum: structure, function, andnew methods to promote repair re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:40:35Z", null, 0, 0, "090000648186f030"], ["FDA-2012-S-1178-0182", "FDA", "FDA-2012-S-1178", "Annex III Lipids of Wheat Flour I. Characterization of Galactosylglycerol Components re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:35:06Z", null, 0, 0, "090000648186f02c"], ["FDA-2012-S-1178-0184", "FDA", "FDA-2012-S-1178", "Annex V Sphingolipids in Wheat Grain re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:37:52Z", null, 0, 0, "090000648186f02e"], ["FDA-2012-S-1178-0202", "FDA", "FDA-2012-S-1178", "Annex XXIII Redacted in its Entirety re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186f05f"], ["FDA-2012-S-1178-0181", "FDA", "FDA-2012-S-1178", "Annex II Bioengineering and subjective approaches to the clinical evaluation of dry skin re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:33:20Z", null, 0, 0, "090000648186f02b"], ["FDA-2012-S-1178-0189", "FDA", "FDA-2012-S-1178", "Annex X Technology of Cereals Third Edition, An Introduction for students of food sciences and Agriculture re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:44:32Z", null, 0, 0, "090000648186f052"], ["FDA-2012-S-1178-0190", "FDA", "FDA-2012-S-1178", "Annex XI Redacted in Its Entirety re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186f053"], ["FDA-2012-S-1178-0180", "FDA", "FDA-2012-S-1178", "E.P.I. France SARL and Seppic Inc. (Ceramosdies Powder Neutra) re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186f02a"], ["FDA-2012-S-1178-0188", "FDA", "FDA-2012-S-1178", "Annex IX Lipids and skin barrier function - a clinical perspective re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:43:21Z", null, 0, 0, "090000648186f032"], ["FDA-2012-S-1178-0192", "FDA", "FDA-2012-S-1178", "Reference List re NDI 774, Annex XIII  Alkaline sphingomyelinases and ceramidases of the gastrointestinal tract from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T12:33:38Z", null, 0, 0, "090000648186f055"], ["FDA-2012-S-1178-0197", "FDA", "FDA-2012-S-1178", "Annex XVIII Water content and thickness of the stratum corneum contribute to skin surface morphology re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:53:23Z", null, 0, 0, "090000648186f05a"], ["FDA-2012-S-1178-0179", "FDA", "FDA-2012-S-1178", "NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Other", "75 Day PreMarket Notification", "2014-09-17T04:00:00Z", 2014, 9, "2014-09-17T04:00:00Z", null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186edc6"], ["FDA-2012-S-1178-0198", "FDA", "FDA-2012-S-1178", "Annex XIX Uptake and Metabolism of Sphingolipids in Isolated Intestinal Loops of Mice re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:55:02Z", null, 0, 0, "090000648186f05b"], ["FDA-2012-S-1178-0187", "FDA", "FDA-2012-S-1178", "Annex VIII Sphingolipids in the human diet - occurrence and implications re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:42:04Z", null, 0, 0, "090000648186f031"], ["FDA-2012-S-1178-0199", "FDA", "FDA-2012-S-1178", "Annex XX Separation and Determination of Glycolipids from Edible Plant Sources by High-PErformance Liquid Chromatography and Evaporative Light Scattering Detection re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:56:06Z", null, 0, 0, "090000648186f05c"], ["FDA-2012-S-1178-0183", "FDA", "FDA-2012-S-1178", "Annex IV The role of epidermal lipids on cutaneous permeability barrier homeostasis re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:36:25Z", null, 0, 0, "090000648186f02d"], ["FDA-2012-S-1178-0191", "FDA", "FDA-2012-S-1178", "E.P.I. France SARL and Seppic Inc. (Ceramosdies Powder Neutra) re Annex XII Selective Extraction and Quantitative Analysis of Non-Starch and Starch Lipids from Wheat Flour - Report 774", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2014-09-17T15:49:51Z", null, 0, 0, "090000648186f054"], ["FDA-2012-S-1178-0196", "FDA", "FDA-2012-S-1178", "NDI 774 re Annez XVII Redacted in its Entirety from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186f059"], ["FDA-2012-S-1178-0201", "FDA", "FDA-2012-S-1178", "Annex XXII Occurance and Biological PRoperties of Sphingolipids - A Review re NDI 774, Ceramosdies Powder Neutra from E.P.I. France SARL and Seppic Inc.", "Supporting & Related Material", "Background Material", "2014-09-17T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:58:31Z", null, 0, 0, "090000648186f05e"], ["FDA-2012-S-1178-0162", "FDA", "FDA-2012-S-1178", "Attachment 6 re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC.  Hui, H., et. al., The formation and Properties of the Melatonin Radical: a Photolysis Study of Melatonin with 248 nm laser light.", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-07-17T18:04:07Z", null, 0, 0, "090000648186d6c2"], ["FDA-2012-S-1178-0176", "FDA", "FDA-2012-S-1178", "Reference List re NDI 772, Myrtol  from G. Pohl Boskamp GmbH & Co. KG", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186e537"], ["FDA-2012-S-1178-0156", "FDA", "FDA-2012-S-1178", "Redacted re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Other", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdf9"], ["FDA-2012-S-1178-0173", "FDA", "FDA-2012-S-1178", "NDI 771, Ceramosides Powder Neutra, E.P.I.  France SARL", "Other", "75 Day PreMarket Notification", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186dedb"], ["FDA-2012-S-1178-0164", "FDA", "FDA-2012-S-1178", "Attachment 8 The EFSA Journal Opinion of the Scientific Panel on Food Additives, Falvourings, Processing Aids and Materials in Contact with Food on a request from the Commission related ot an application on the use of polyethylene glycol (PEG) as a film coating for agent use in food supplement products  re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC.", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d6c4"], ["FDA-2012-S-1178-0165", "FDA", "FDA-2012-S-1178", "Attachment 9 Redacted re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d6c5"], ["FDA-2012-S-1178-0171", "FDA", "FDA-2012-S-1178", "NDI 770, Astragalus extract TA-65 from Telomerase Activation Sciences aka TA Sciences", "Other", "75 Day PreMarket Notification", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d8e3"], ["FDA-2012-S-1178-0166", "FDA", "FDA-2012-S-1178", "Attachment 10 Redacted re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d6c6"], ["FDA-2012-S-1178-0172", "FDA", "FDA-2012-S-1178", "Reference List re NDI 770, Astragalus extract TA-65 from Telomerase Activation Sciences aka TA Sciences", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-07-22T12:01:53Z", null, 0, 0, "090000648186debe"], ["FDA-2012-S-1178-0158", "FDA", "FDA-2012-S-1178", "Attachment 2 re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdfc"], ["FDA-2012-S-1178-0163", "FDA", "FDA-2012-S-1178", "Attachment 7 re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d6c3"], ["FDA-2012-S-1178-0167", "FDA", "FDA-2012-S-1178", "Attachment 11 Redacted re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d6c7"], ["FDA-2012-S-1178-0157", "FDA", "FDA-2012-S-1178", "Attachment 1 Redacted re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdfb"], ["FDA-2012-S-1178-0174", "FDA", "FDA-2012-S-1178", "Reference List re NDI 771, Ceramosides Powder Neutra from E.P.I.  France SARL", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2017-11-28T13:18:13Z", null, 0, 0, "090000648186dede"], ["FDA-2012-S-1178-0161", "FDA", "FDA-2012-S-1178", "Attachment 5 re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdff"], ["FDA-2012-S-1178-0177", "FDA", "FDA-2012-S-1178", "NDI 773, Sodium butyrate from Biolek Inc", "Other", "75 Day PreMarket Notification", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186e806"], ["FDA-2012-S-1178-0160", "FDA", "FDA-2012-S-1178", "Attachment 4  Redacted  re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdfe"], ["FDA-2012-S-1178-0175", "FDA", "FDA-2012-S-1178", "NDI 772 Myrtol: oil of eucalyptus, sweet orange, lemon, and myrtle from G. Pohl Boskamp GmbH & Co. KG", "Other", "75 Day PreMarket Notification", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:09Z", null, 0, 0, "090000648186e535"], ["FDA-2012-S-1178-0170", "FDA", "FDA-2012-S-1178", "Liaoning Koncepnutra Co. Ltd (L-Carnitine Calcium Fumarate) re Premarket Notification for New Dietary Ingredient L-Carnitine Calcium Fumarate - Report 769", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2014-09-12T15:16:45Z", null, 0, 0, "090000648186d863"], ["FDA-2012-S-1178-0169", "FDA", "FDA-2012-S-1178", "Liaoning Koncepnutra Co. Ltd (L-Carnitine Calcium Fumarate) - Report 769", "Other", "Report", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d810"], ["FDA-2012-S-1178-0159", "FDA", "FDA-2012-S-1178", "Attachment 3 NNFA List of Dietary Supplement Ingredients re NDI 756, Melatonin with Excipient Polyethylene Glycol PEG8000 REMfresh, Zx Pharma LLC", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186cdfd"], ["FDA-2012-S-1178-0178", "FDA", "FDA-2012-S-1178", "NDI 773, Sodium butyrate from Biolek Inc re Attachments 2 through 8", "Supporting & Related Material", "Background Material", "2014-09-12T04:00:00Z", 2014, 9, null, null, "2016-07-22T02:15:21Z", null, 0, 0, "090000648186e8a7"], ["FDA-2012-S-1178-0168", "FDA", "FDA-2012-S-1178", "NDI 768, Cyclic Polylactate (CPL) and Polylactate (PL) from Life Trade Co., Ltd.", "Other", "75 Day PreMarket Notification", "2014-09-12T04:00:00Z", 2014, 9, "2014-09-12T04:00:00Z", null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186d7c6"], ["FDA-2012-S-1178-0147", "FDA", "FDA-2012-S-1178", "Attachment 4 of 6 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:29:45Z", null, 0, 0, "090000648186bad8"], ["FDA-2012-S-1178-0144", "FDA", "FDA-2012-S-1178", "Attachment 1 of 6 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:22:54Z", null, 0, 0, "090000648186bb0e"], ["FDA-2012-S-1178-0155", "FDA", "FDA-2012-S-1178", "Reference List re NDI 767, Polyglycoplex from InovoBiologic, Inc.", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-20T22:55:04Z", null, 0, 0, "090000648186c1e5"], ["FDA-2012-S-1178-0148", "FDA", "FDA-2012-S-1178", "Attachment 5 of 6 - Report 764 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:31:59Z", null, 0, 0, "090000648186bad9"], ["FDA-2012-S-1178-0145", "FDA", "FDA-2012-S-1178", "Attachment 2 of 6 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:26:23Z", null, 0, 0, "090000648186bad6"], ["FDA-2012-S-1178-0153", "FDA", "FDA-2012-S-1178", "NDI 767, Polyglycoplex from InovoBiologic, Inc.", "Other", "75 Day PreMarket Notification", "2014-09-11T04:00:00Z", 2014, 9, "2014-09-11T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648186c1e0"], ["FDA-2012-S-1178-0146", "FDA", "FDA-2012-S-1178", "Attachment 3 of 6 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:28:11Z", null, 0, 0, "090000648186bad7"], ["FDA-2012-S-1178-0149", "FDA", "FDA-2012-S-1178", "Attachment 6 of 6 re NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:33:33Z", null, 0, 0, "090000648186bb0d"], ["FDA-2012-S-1178-0151", "FDA", "FDA-2012-S-1178", "Reference List re NDI 765, Curry Leaf from Kavan Life and Computing Private Limited", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-07-20T22:55:54Z", null, 0, 0, "090000648186c19d"], ["FDA-2012-S-1178-0154", "FDA", "FDA-2012-S-1178", "Refrence List re NDI 767, Polyglycoplex from InovoBiologic, Inc. (Polyglycoplex [PGX]) re New Dietary Ingredient Notification for Polyglycoplex (PGX) - Report 767", "Supporting & Related Material", "Background Material", "2014-09-11T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:08Z", null, 0, 0, "090000648186c1e4"], ["FDA-2012-S-1178-0150", "FDA", "FDA-2012-S-1178", "NDI 765, Curry Leaf Extract from Kavan Life and Computing Private Limited", "Other", "75 Day PreMarket Notification", "2014-09-11T04:00:00Z", 2014, 9, "2014-09-11T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648186c19b"], ["FDA-2012-S-1178-0152", "FDA", "FDA-2012-S-1178", "NDI 766, Achachairu from Natural Discoveries Inc dba CuraCaza", "Other", "75 Day PreMarket Notification", "2014-09-11T04:00:00Z", 2014, 9, "2014-09-11T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648186c1dd"], ["FDA-2012-S-1178-0143", "FDA", "FDA-2012-S-1178", "NDI 764, Lactobacillus plantarum HK-LP 137, Immuno-LP20 from House Wellness Foods Corporation", "Other", "75 Day PreMarket Notification", "2014-09-11T04:00:00Z", 2014, 9, "2014-09-11T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648186bad2"], ["FDA-2012-S-1178-0142", "FDA", "FDA-2012-S-1178", "Exhibits 48 through 57 re NDI 763, Apoaequorin, Prevagen from Quincy Manufacturing Sciences", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:10:29Z", null, 0, 0, "0900006481869e7e"], ["FDA-2012-S-1178-0131", "FDA", "FDA-2012-S-1178", "Glock Health GmbH (Clinoptilolite) re Exhibits 66 through 70 - Report 760", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2014-09-10T19:43:16Z", null, 0, 0, "090000648185f98e"], ["FDA-2012-S-1178-0137", "FDA", "FDA-2012-S-1178", "NDI 762, Agarikon and Mykoprotect from Health and Mushrooms", "Other", "75 Day PreMarket Notification", "2014-09-10T04:00:00Z", 2014, 9, "2014-09-10T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185fb1f"], ["FDA-2012-S-1178-0132", "FDA", "FDA-2012-S-1178", "NDA 761, Syringa vulgaris (Lilac) dry cell culture extract, Dermasyr 50 from I.R.B. Istituto di Ricerche Biotecnologiche S.p.A.", "Other", "75 Day PreMarket Notification", "2014-09-10T04:00:00Z", 2014, 9, "2014-09-10T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f990"], ["FDA-2012-S-1178-0129", "FDA", "FDA-2012-S-1178", "Exhibits 58 Through 64 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T01:47:29Z", null, 0, 0, "090000648185f71e"], ["FDA-2012-S-1178-0133", "FDA", "FDA-2012-S-1178", "Pre-market Notification of Syringa vulgaris (Lilac) Tissue Culture Extract as New Dietary Ingredient re NDA 761, Syringa vulgaris (Lilac) dry cell culture extract, Dermasyr 50 from I.R.B. Istituto di Ricerche Biotecnologiche S.p.A.", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f992"], ["FDA-2012-S-1178-0125", "FDA", "FDA-2012-S-1178", "Exhibits 11 Through 21 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T01:32:36Z", null, 0, 0, "090000648185f71a"], ["FDA-2012-S-1178-0127", "FDA", "FDA-2012-S-1178", "Exhibits 24 Through 27 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T01:40:16Z", null, 0, 0, "090000648185f71c"], ["FDA-2012-S-1178-0135", "FDA", "FDA-2012-S-1178", "Bibliography References 1 Through 12 re NDA 761, Syringa vulgaris (Lilac) dry cell culture extract, Dermasyr 50 from I.R.B. Istituto di Ricerche Biotecnologiche S.p.A.", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T02:20:45Z", null, 0, 0, "0900006481869d75"], ["FDA-2012-S-1178-0140", "FDA", "FDA-2012-S-1178", "Exhibits 1 Through 23 re NDI 763, Apoaequorin, Prevagen from Quincy Manufacturing Sciences", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T02:56:44Z", null, 0, 0, "0900006481869e7c"], ["FDA-2012-S-1178-0130", "FDA", "FDA-2012-S-1178", "Exhibit 65 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f725"], ["FDA-2012-S-1178-0134", "FDA", "FDA-2012-S-1178", "Attachments 1 Through 14 re NDA 761, Syringa vulgaris (Lilac) dry cell culture extract, Dermasyr 50 from I.R.B. Istituto di Ricerche Biotecnologiche S.p.A.", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "0900006481869d74"], ["FDA-2012-S-1178-0123", "FDA", "FDA-2012-S-1178", "Exhibits 1 Through 3 Cited Reference Material re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T01:24:42Z", null, 0, 0, "090000648185f718"], ["FDA-2012-S-1178-0128", "FDA", "FDA-2012-S-1178", "Exhibits 28 Through 57 Redacted in Its Entirety re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f71d"], ["FDA-2012-S-1178-0141", "FDA", "FDA-2012-S-1178", "Exhibits 24 through 45 re NDI 763, Apoaequorin, Prevagen from Quincy Manufacturing Sciences", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T03:04:51Z", null, 0, 0, "0900006481869e7d"], ["FDA-2012-S-1178-0139", "FDA", "FDA-2012-S-1178", "NDI 763, Apoaequorin, Prevagen from Quincy Manufacturing Sciences", "Other", "75 Day PreMarket Notification", "2014-09-10T04:00:00Z", 2014, 9, "2014-09-10T04:00:00Z", null, "2016-10-27T15:20:07Z", null, 0, 0, "0900006481869e08"], ["FDA-2012-S-1178-0124", "FDA", "FDA-2012-S-1178", "Exhibits 4 Through 10 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f719"], ["FDA-2012-S-1178-0138", "FDA", "FDA-2012-S-1178", "Addendum 1 Through 4 Reference Material re NDI 762, Agarikon and Mykoprotect from Health and Mushrooms", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T02:40:32Z", null, 0, 0, "090000648185fb21"], ["FDA-2012-S-1178-0126", "FDA", "FDA-2012-S-1178", "Exhibits 22 Through 23 re NDI 760, Clinoptilolite from Glock Health GmbH", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:07Z", null, 0, 0, "090000648185f71b"], ["FDA-2012-S-1178-0136", "FDA", "FDA-2012-S-1178", "Bibliography References 13 Through 22 re NDA 761, Syringa vulgaris (Lilac) dry cell culture extract, Dermasyr 50 from I.R.B. Istituto di Ricerche Biotecnologiche S.p.A.", "Supporting & Related Material", "Background Material", "2014-09-10T04:00:00Z", 2014, 9, null, null, "2016-07-19T02:24:26Z", null, 0, 0, "090000648185f993"], ["FDA-2012-S-1178-0113", "FDA", "FDA-2012-S-1178", "Attachment J United States Patent - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cd9d"], ["FDA-2012-S-1178-0120", "FDA", "FDA-2012-S-1178", "Attachment Q Bioactive Compounds and Cancer, Mechanismsof Action of Isoflaavones in Cancer Prevention - NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:38:31Z", null, 0, 0, "090000648185cdaa"], ["FDA-2012-S-1178-0121", "FDA", "FDA-2012-S-1178", "Attachment R Voytko, M.L., et. al., The American Journal of Primatol, Neuroprotective effects of Estrogen Therapy for Cognitive and Neurobiological Profiles of Monkey Models of Menopause - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cdab"], ["FDA-2012-S-1178-0119", "FDA", "FDA-2012-S-1178", "Attachment P Drogos, L., Geller, S., Maki, P., University of Illinois Departments of Psychology1 Psychiatry2 and Obstetric and Gynecology 3, Soy and Cognition in the Aging Population - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:38:06Z", null, 0, 0, "090000648185cda9"], ["FDA-2012-S-1178-0122", "FDA", "FDA-2012-S-1178", "NDI 760, Clinoptilolite from Glock Health GmbH", "Other", "75 Day PreMarket Notification", "2014-09-05T04:00:00Z", 2014, 9, "2014-09-05T04:00:00Z", null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185f6e0"], ["FDA-2012-S-1178-0116", "FDA", "FDA-2012-S-1178", "Attachment M Qing-Qi, S. et. al., pg. 601, Huperzine-A capsules enhance memory and learning performance in 34 pairs of matched adolescent students - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cda6"], ["FDA-2012-S-1178-0112", "FDA", "FDA-2012-S-1178", "Attachment I Determination of huperzine A in human plasma by liquid chromatography - electrospray tandem mass spectrometry: application to a bioequivalence study on Chinese volunteers - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:34:46Z", null, 0, 0, "090000648185cd9c"], ["FDA-2012-S-1178-0114", "FDA", "FDA-2012-S-1178", "Attachment K European Journal of Gastroenterology & Hepatology 2009, Vol 21, No 6 References - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:35:24Z", null, 0, 0, "090000648185cd9e"], ["FDA-2012-S-1178-0115", "FDA", "FDA-2012-S-1178", "Attachment L Woolf, Graham, et. al., Annals of Internal Medicine, Acute Hepatitis Associated with the Chinese Herbal Product Jin Bu Huan, Volume 121, Number 10 - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:35:51Z", null, 0, 0, "090000648185cda5"], ["FDA-2012-S-1178-0118", "FDA", "FDA-2012-S-1178", "Attachment O The Journal of The North American Menopause Society, NAMS 2011 Isoflavones Report, The role of Soy isoflavones in menopausal health: report of The North American Menopause Society/Wulf H. Utian Translational Science Symposium in Chicago, IL (October 2010) - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:37:45Z", null, 0, 0, "090000648185cda8"], ["FDA-2012-S-1178-0111", "FDA", "FDA-2012-S-1178", "Attachment H Redacted in Its Entirety - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cd9b"], ["FDA-2012-S-1178-0117", "FDA", "FDA-2012-S-1178", "Attachment N GRAS Notification for Isoflavones Derived from Soybeans, Provided by: The Archer Daniels Midland 'Company - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-05T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cda7"], ["FDA-2012-S-1178-0102", "FDA", "FDA-2012-S-1178", "Table of Contents - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:27:09Z", null, 0, 0, "090000648185cd7e"], ["FDA-2012-S-1178-0104", "FDA", "FDA-2012-S-1178", "Attachment A Redacted in Its Entirety - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cd80"], ["FDA-2012-S-1178-0110", "FDA", "FDA-2012-S-1178", "Attachment G Expert Opinion, An Update on Huperzine A as a treatment for Alzheimer's Disease - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:33:08Z", null, 0, 0, "090000648185cd9a"], ["FDA-2012-S-1178-0105", "FDA", "FDA-2012-S-1178", "Attachment B ITIS Report - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-10-27T15:20:06Z", null, 0, 0, "090000648185cd82"], ["FDA-2012-S-1178-0109", "FDA", "FDA-2012-S-1178", "Attachment F Acta Pharmacologica Sinica Progress in studies of huperzine A, a natural cholinestrerase inhibitor from Chineseherbal medicine - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:32:40Z", null, 0, 0, "090000648185cd99"], ["FDA-2012-S-1178-0103", "FDA", "FDA-2012-S-1178", "Sections I-IV - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", "Background Material", "2014-09-04T04:00:00Z", 2014, 9, null, null, "2016-07-17T14:27:37Z", null, 0, 0, "090000648185cd7f"], ["FDA-2012-S-1178-0108", "FDA", "FDA-2012-S-1178", "Attachment E Evaluation of a new Class 1 Substance - re: NDI 759 Huperzine A from CogniFem LLC", "Supporting & Related Material", 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