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withdrawn,object_id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-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,,,2016-07-22T12:32:38Z,,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,,,2016-07-22T12:33:59Z,,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,,,2016-10-27T15:20:09Z,,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,,,2016-07-22T12:32:58Z,,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,,,2016-07-22T02:57:19Z,,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,,,2016-07-22T02:40:35Z,,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,,,2016-07-22T02:35:06Z,,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,,,2016-07-22T02:37:52Z,,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,,,2016-10-27T15:20:09Z,,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,,,2016-07-22T02:33:20Z,,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,,,2016-07-22T02:44:32Z,,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,,,2016-10-27T15:20:09Z,,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,,,2016-10-27T15:20:09Z,,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,,,2016-07-22T02:43:21Z,,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,,,2016-07-22T12:33:38Z,,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,,,2016-07-22T02:53:23Z,,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,,2016-10-27T15:20:09Z,,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,,,2016-07-22T02:55:02Z,,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,,,2016-07-22T02:42:04Z,,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,,,2016-07-22T02:56:06Z,,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,,,2016-07-22T02:36:25Z,,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,,,2014-09-17T15:49:51Z,,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,,,2016-10-27T15:20:09Z,,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,,,2016-07-22T02:58:31Z,,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,,,2016-07-17T18:04:07Z,,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,,,2016-10-27T15:20:09Z,,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,,2016-10-27T15:20:08Z,,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,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-07-22T12:01:53Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2017-11-28T13:18:13Z,,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,,,2016-10-27T15:20:08Z,,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,,2016-10-27T15:20:09Z,,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,,,2016-10-27T15:20:08Z,,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,,2016-10-27T15:20:09Z,,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,,,2014-09-12T15:16:45Z,,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,,2016-10-27T15:20:08Z,,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,,,2016-10-27T15:20:08Z,,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,,,2016-07-22T02:15:21Z,,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,,2016-10-27T15:20:08Z,,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,,,2016-07-19T03:29:45Z,,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,,,2016-07-19T03:22:54Z,,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,,,2016-07-20T22:55:04Z,,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,,,2016-07-19T03:31:59Z,,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,,,2016-07-19T03:26:23Z,,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,,2016-10-27T15:20:07Z,,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,,,2016-07-19T03:28:11Z,,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,,,2016-07-19T03:33:33Z,,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,,,2016-07-20T22:55:54Z,,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,,,2016-10-27T15:20:08Z,,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,,2016-10-27T15:20:07Z,,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,,2016-10-27T15:20:07Z,,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,,2016-10-27T15:20:07Z,,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,,,2016-07-19T03:10:29Z,,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,,,2014-09-10T19:43:16Z,,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,,2016-10-27T15:20:07Z,,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,,2016-10-27T15:20:07Z,,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,,,2016-07-19T01:47:29Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-07-19T01:32:36Z,,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,,,2016-07-19T01:40:16Z,,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,,,2016-07-19T02:20:45Z,,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,,,2016-07-19T02:56:44Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-07-19T01:24:42Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-07-19T03:04:51Z,,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,,2016-10-27T15:20:07Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-07-19T02:40:32Z,,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,,,2016-10-27T15:20:07Z,,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,,,2016-07-19T02:24:26Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:38:31Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:38:06Z,,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,,2016-10-27T15:20:06Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:34:46Z,,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,,,2016-07-17T14:35:24Z,,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,,,2016-07-17T14:35:51Z,,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,,,2016-07-17T14:37:45Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:27:09Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:33:08Z,,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,,,2016-10-27T15:20:06Z,,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,,,2016-07-17T14:32:40Z,,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,,,2016-07-17T14:27:37Z,,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,Background Material,2014-09-04T04:00:00Z,2014,9,,,2016-07-17T14:32:11Z,,0,0,090000648185cd98
FDA-2012-S-1178-0101,FDA,FDA-2012-S-1178,NDI 759 Huperzine A from CogniFem LLC,Other,75 Day PreMarket Notification,2014-09-04T04:00:00Z,2014,9,2014-09-04T04:00:00Z,,2016-10-27T15:20:06Z,,0,0,090000648185c3fc