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181 rows where docket_id = "FDA-2012-S-1178" and posted_year = 2014 sorted by posted_date descending

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  • 2014 · 181 ✖

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2012-S-1178-0194 FDA None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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