Regulatory Information
OTC Panel Submissions (Indices Only): 15 - Vitamin and Mineral
Public Administrative File
OTC Vitamin and Mineral Drug Products
(Docket No. 78N-0024)
| VOLUME | SUBMITTED BY | TRADE NAME/SUBJECT |
|---|---|---|
| 150001 | Schering Corp. |
Mol-Iron Liquid Mol-Iron Tablets Mol-Iron Chronosule Tablets |
| 150002 | The Central Pharmacal Co. |
Niferex Tablets Niferex Elixir Niferex-150 Capsules |
| 150003 | Marion Laboratories, Inc. | Os-Cal tablets |
| 150004 | Mallinckrodt Chemical Works |
Toleron Suspension Toleron Tablets |
| 150005 | Eastman Chemical Products, Inc. | Vitamin E |
| 150006 | Ross laboratories | Proposed Products for Women on Oral Contraceptives |
| 150007 | International Pharmaceutical Corp. | Calcident Tablets |
| 150008 | Smith Kline & French Laboratories | Feosol Spansule Capsules |
|
150009- 150010 |
Cooper laboratories, Inc. |
Ferronord Tablets Vitron-C Hematinic Tablets |
| 150011 | Merrell-National Laboratories | Simron Plus Capsules |
| 150012 | Merrell-National Laboratories | Simron Capsules |
| 150013 | A.H. Robins Co. | Allbee-T Mult-vitamins |
| 150014 | A.H. Robins Co. |
Adabee Multivitamins Adabe with Minerals Tables |
| 150015 | A.H. Robins Co. |
Allbee Capsules Allbee w/C Capsules |
| 150016 | E.R. Squibb & Sons, Inc. |
Theragran Tablets Theragran Liquid Theragran-M Tablets |
| 150017 | E.R. Squibb & Sons, Inc. |
Vitamin B-1 100mg Tablets Vitamin B-1 50mg Tablets |
| 150018 | E.R. Squibb & Sons, Inc. | Iron with Vitamin C Tablets |
| 150019 | E.R. Squibb & Sons, Inc. | Vitamin B-12 Capsules |
| 150020 | E.R. Squibb & Sons, Inc. | Niacin Tablets |
| 150021 | E.R. Squibb & Sons, Inc. |
Vitamin A from Natural Sources Capsules Vitamin A Capsules |
| 150022 | E.R. Squibb & Sons, Inc. |
B Complex with Vitamin C Capsules Stress Formula B Complex with Vitamin C Tablets |
| 150023 | E.R. Squibb & Sons, Inc. |
Vitamin C Tablets Vitamin C Vitamin C Tablets (Golden Bountry) |
| 150024 | E.R. Squibb & Sons, Inc. |
Vitamin E Walnut Flavored Tablets Vitamin E Capsules Natural Vitamin E Capsules |
| 150025 | Pfizer Pharmaceuticals |
Crystalets Vitamin A Palmilets Stablets |
|
150026- 150027 |
Hoffmann-LaRoche, Inc. | Vitamin A |
| 150028 | Hoffmann-LaRoche, Inc. | Thiamine |
| 150029 | Hoffmann-LaRoache, Inc. | Riboflavin |
| 150030 | Hoffmann-LaRoache, Inc. | Niacin |
| 150031 | Hoffmann-LaRoache, Inc. | Vitamin B-6 |
| 150032 | Hoffmann-LaRoache, Inc. | Panthothenic Acid |
|
150033- 150034 |
Hoffmann-LaRoache, Inc. | Ascorbic Acid |
| 150035 | Hoffmann-LaRoache, Inc. | Vitamin E |
| 150036 | Hoffmann-LaRoache, Inc. | Biotin |
| 150037 | Lederle Laboratories |
Filibon Prenatal Capsules Filbon OT Prenatal Tablets Gevrabon Vitamin Mineral Supplement Gevral Capsules Gevral T Capsules Gevral Protein Gevrite Tablets Lederplex Capsules Lederplex Liquid Lederplex Tablets Stresscaps Stresstabs 600 Vi-Magna Capsules Ferro-Mandets Tablets Ferro-Sequels Capsules Incremin with Iron Syrup Peritinic Tablets Recoup Tablets |
| 150038 | William H. Rorer, Inc. | Fermalox Tablets |
| 150039 | Abbott Laboratories |
Fero-Gradumet Filmtab Fero-Grad-500 Filmtabs Iberet Filmtab Tablets Iberet Liquid Iberet-500 Filmtab Tablet Iberet -500 Liquid Iberol Filmtab Tablets Iberol-F Filmtab Tablets Daylong Tablets |
| 150040 | Abbott Laboratories |
Optilets-500 Filmtab Tablets Optilets-M-500 Filmtab Tablets Surbex Filmtab Tablets Surbex w/C Filmtab Tablets Surbex-T Filmtab Tablets |
| 150041 | ICI America Inc. |
Ferancee Hematinic Tablets Ferancee-HP Hematinic Tablets Orexin Therapeutic Vitamin Supplement Tablets Probec Tablets Probec-T Tablets Theron Tablets Stuart Therapeutic Multivitamin Tablets Stuart Hematinic Liquid Stuart Hematinic Tablets Mucoplex Tablets Stuartinic Hematinic Tablets |
| 150042 | Plus Products |
Plus Formula 10 Multimineral Tablets Plus Formula 14 Multi-mins Tablets Plus Formula 15 Multi-mins Tablets Plus Formula 22 Magnesium Oxide Powder Plus Formula 23 Manganese Tablets Plus Formula 49 Vitamin B Complex Tablets Plus Formula 49A Vitamin B Complex Tablets Plus Formula 50 Liver, Iron & B Vitamins Tablets Plus Formula 70 Vitamin B Complex Tablets with Vitamin C Plus Formaula 71 High Potency Vitamin B Complex with Vitamin C Tablets Plus Formula 72 Stress Supplement Tablets Plus Formula 74 Vitamin & Mineral Supplement Perles Plus Formula 75 B Complex 75 Tablets Plus Formula 77 Vitamin B Complex Syrup with Iron Plus Formula 78 Vitamin Syrup for Children Plus Formula 80A Bone Meal Powder Plus Formula 85 Natural Bone Meal with Magnesium, Manganese & Zinc Tablets Plus Formula 92 Granular Soya Lecithin Plus Formula 93A Lecithin Perles Plus Formula 100 DFS Perles Plus Formula 101A Vitamin A Perles Plus Formula 104A Emulsified A Perles Plus Formula 123 Paraaminobenzoic Acid (PABA) Tablets Plus Formula 125A Inositol Tablets Plus Formula 126 Inositol Powder Plus Formula 152 Emulsified Vitamin E Complex Perles Plus Formula 153 Vitamin E Complex Perles |
| 150042 cont.......... |
Plus Formula 154A Emulsified Vitamin E Complex Perles Plus Formula 155 Vitamin E Complex Perles Plus Formula 156 Vitamin E Complex Perles Plus Formula 158 Vitamin E Tablets Plus Formula 159 Vitamin E Perles Plus Formula 162 Vitamin E Perles Plus Formula 163 Vitamin E Perles Plus Formula 164 Vitamin E Perles Plus Formula 165 Vitamine E Perles Plus Formula 175 Dietary Food Supplement Perles Plus Formula 180 Potassium & Iodine Tablets Plus Formula 184 Calcium and Magnesium Tablets Plus Formula 202A Vitamins A & D Perles Plus Formula 203A Vitamins A & D Tablets Plus Formula 205A Vitamins A,D, 7 E Perles Plus Formula 206 A, D & E Drops Plus Formula 207 Vitamins A & Plus Formula 222 High Potency Cod Liver Oil Plus Formula 234 Vitamin B-1 Tablets Plus Formula 242 Vitamin B-2 Tablets Plus Formula 249 Dried Yeast Tablets Plus Formula 250 Yeast Plus Plus Formula 251 Vitamin B-6 Tablets Plus Formula 252 Vitamin B-6 Tablets Plus Formula 253 Vitamin B-6 Tablets Plus Formula 260 Niacin Tablets Plus Formula 263 Niacinamide Tablets Plus Formula 264A Pantothenic Acid Tablets Plus Formula 265A Acerola Chews Tablets Plus Formula 266A Chewable Vitamin C Tablets |
|
| 150042 cont.... |
Plus Formula 267A Chewable Vitamin C Tablets Plus Formula 273A Vitamin C Tablets Plus Formula 275 Vitamin C Complex Plus Formula 277 Vitamin C Complex Plus Formula 278 Vitamin C Powder Plus Formula 279 Vitamin C Powder Plus Formula 280A Vitamin C Tablets Plus Formula 282 Vitamin C Complex Tablets Plus Formula 290 Granular Kelp Plus Formula 304 Vitamin B-12 Tablets Plus Formula 333 Dried Yeast and Iron Tablets Plus Formula 380 Mint-A-Mins Chewable Vitamin Wafers Plus Formula 450 Instant Brewer’s Yeast Plus Formula 445 Iron Supplement Tablets Plus Formula 740 Tiger’s Milk Cookies Plus Formula 745 Tiger’s Milk Carob Coated Bar Plus Formula 746 Tiger’s Milk Real Peanut Butter Bar Plus Formula 747 Tiger’s Milk Peanut Butter & Honey Bar Plus Formula 748 Tiger’s milk Peanut Butter & Jelly Bar Plus Formula 749 Tiger’s Milk Calorie Watcher’s Snack Plus Formula 800 Tiger’s Milk Nutrition Booster Plain Plus Formula 825 Tiger’s Milk Nutrition Booster Natural Carob Flavor Plus Formula 850 Tiger’s Milk Nutrition Booster Vanilla Flavor Plus Formula 875 Nutrition Booster Natural Cocoa Flavor Plus Formula 86 Zinc 30mg Tablets Plus Formula 87 Zinc Tablets Plus Formula 98 Vita-Fems Tablets Plus Formula 122 PABA Tablets |
|
| 150042 cont............ |
Plus Formula 127 Choline Tablets Plus Formula 128 Inositol Tablets Plus Formula 157 Vitamin E Capsules Plus Formula 160 Vitamin E Capsules Plus Formula 166 Vitamin E Capsules Plus Formula 243 Vitamin B-2 Tablets Plus Formula 244 Vitamin B-2 Tablets Plus Formula 259 Pantothenic Acid Tablets Plus Formula 261 Niacin Tablets Plus formula 262 Niacinamide Tablets Plus Formula 303 Vitamin B-12 Tablets |
|
|
150043- 150047 |
The J.B. Williams Company, Inc. |
Geritol Liquid Geritol Tablets |
| 150048 | Ross Laboratories | Alpha Tocopheryl Polyethylene Glycol 1000 Succinate |
| 150049 | Signet Laboratories Incorporated |
B-12 Tablets Double Absorption B-12 Tablets Vitamin B-6 Tablets Vitamin B-1 Tablets Vitamin B-2 Tablets Double Absorption B-12 Tablets Anti-X Tablets pantothenic Acid Tablets Citrex Plus Tablets Toco E Sol Tablets Taste-E-Tab Power-B w/PABA Tablets Intensive Care B with C Tablets Premium Nutrition Plan Tablets Omni Nutrition Plan Tablets One Plan Multi-Vitamin-Mineral Supplement Tablets Ultra-Vite Multi-Vitamin-Mineral Supplement Tablets Neo-Tone Asimicaps Iron with Vitamins & Minerals Tablets Mag-Cal Balanced Super Citrex Tablets |
|
150050- 150052 |
McMurray & Pendergast (For Vita-minerals, Inc.) | Bioflavanoids |
| 150053 | A.E. Staley Manufacturing Co. | Inositol |
| 150054 | LaWall & Harrison Research Laboratories, Inc. | S.S.S. Tonic Tablets |
| 150055 | LaWall & Harrison Research Laboratories, Inc. | S.S.S. Tonic (Liquid) |
| 150056 | Mead Johnson Laboratories | Feminins Tablets |
| 150057 | Sterling Drug Inc. |
Fergon Capsules Fergon w/C Caplets Fergon Compound Elixir Fergon Elixir Fergon Tablets Ironized Yeast Tablets |
| 150058 | Sterling Drug Inc. | Afaxin Capsules |
| 150059 | Sterling Drug Inc. | Betaxin Tablets |
| 150060 | Sterling Drug Inc. | Drisdol |
| 150061 | Sterling Drug Inc. |
Pluravit Capsules Pluraxin Capsules |
| 150062 | Wm. T. Thompson Co. |
Zinc Tablets Trace Elements Tablets Fluoride Tablets Multi-Minerals w/Sea Minerals Tablets |
| 150063 | Wm. T. Thompson Co. |
Vitamin A Tablets Vitamin A & Vitamin D Capsules Vitamin D Tablets Vitamin E Tablets Vitamin E Capsules Vitamin E & C with A Capsules Vitamin K-1 Tablets |
| 150064 | Wm. T. Thompson Co. |
Acerola C Chewable Tablets Vitamin C Tablets One Gram C Capsules C Ross Hips Tablets C-Flavoids “500" Tablets Rose Hips C-Flavoids “650" Tablets Flavoid Complex Tablets |
| 150065 | Wm. T. Thompson Co. |
Ex-Po 36 Capsules (proposed) Ex-Po 36 Capsules Nuplex Tablets Iron Hematinic Tablets Neo-Globin Tablets |
| 150066 | Wm. T. Thompson Co. |
Vitamin B-1 Tablets Vitamin B-2 Tablets Vitamin B-6 Tablets Vitamin B-12 Tablets B Complex Plus C Tablets B Complex “50" Tablets (proposed) B-Complex “50" Capsules B-Complex Capsules (proposed) Niacin Tablets NiacinamideTablets Pantothenic Acid Tablets Folic Acid Tablets |
| 150067 | Ayerst Laboratories |
Beminal 500 Tablets Beminal Forte with Vitamin C Capsules Beninal Vitamin B Complex with Iron and Liver Capsules Cytoferin Tablets Clusivol Chew Tablets Clusivet Tablets Clusivol Syrup |
|
150068- 150069 |
Vitaminerals, Inc. | Data and views on Vitamin D |
|
150070- 150071 |
Vitaminerals, Inc. | Data and views on Vitamin A |
| 150072 | see 150126 | |
| 150073 | The Council for Responsible Nutrition | Example labels of member companies. Safety and Efficacy review for Vitamins A, C, E, Niacin and fat soluable vitamin combinations-Data & Views |
| 150074 | The Council for Responsible Nutrition | Vitamin A reference bibliography. |
| 150075 | The Council for Responsible Nutrition | Ascorbic reference bibliography |
| 150076 | The Council for Responsible Nutrition | Reference bibliography for Vitamin E. |
| 150077 | The Council for Responsible Nutrition | Reference bibliography for Niacin and Niacinamide |
| 150078 | The Council for Responsible Nutrition | Reference bibliography for fat-soluble vitamins (A, E, D). |
| 150079 | Radiance Products Co. |
Super Potency Multiple Vitamins & Minerals Tablets Norwegian Cod Liver Oil w/Vegetable Oils Capsules Vitamin B-6 Tablets Vitamin B-12 in a Special Base Tablets Super B-Complex Plus C Capsules Dry Aqua-E Tablets Bone Meal Plus Vitamin D and Iron Tablets Proportioned Magnesium Tablets Chewable Tasti C with Bioflavanoid Wafers |
|
150080- 150081 |
Vitaminerals, Inc. | Data and views on Iron indications, Use and Toxicity |
| 150082 | Dorsey Laboratories | Neo-Calglucon Syrup |
|
150083- 150084 |
Vitaminerals, Inc. | Information on Magnesium. |
|
150085- 150087 |
Vitaminerals, Inc. | Information on lipotropic substances-discussion and summary. |
| 150088 | Vitaminerals, Inc. | Information on vitamins, minerals and hematinic - discussion and summary |
| 150089 | Cooper Laboratories, Inc. | Vitron-C Iron Therapy |
| 150090 | General Mills Chemicals, Inc. | Vitamin E |
| 150091 | R.L. Gaddy |
Vita-Pep Tablets |
| 150091A | TPR Pharmaceuticals, Inc. | B-Tinic |
| 150092 | Cooper Laboratories, Inc. | Supplemental to a submission of ferrous fumarate-ascrbic acid bibliography |
| 150093 | Ross Laboratories | Supplemental to volume 150048. Animal data on water soluble vitamin E. |
| 150094 | General Mills Chemicals, Inc. | Material on Vitamin E |
| 150095 | Abbott Laboratories | Supplemental submission to volumes 150039-150040. |
|
150096- 150104 |
Hoffman-LaRoche, Inc. | Summary of the data on safety and efficacy of: Vitamin A, Thiamine, Riboflavin, Niacin, Vitamin B-6, Pantothenic Acid, Ascorbic Acid, Vitamin E, Biotin. |
| 150105 | Smith, Kline & French Laboratories | Triamterene |
| 150106 | E.R. Squibb & Sons, Inc. | Supplemental submission on Theragran Tablets and Thergran-M Tablets. |
| 150107 | Hoffman-LaRoche, Inc. | Absorption techniques and absorption data on vitamins in pharmaceutical products. |
| 150108 | Hoffman-LaRoche, Inc. | Manufacturing overages of vitamins in pharaceutical products. |
| 150109 | Hoffman-LaRoche, Inc. | Critical review of vitamin C -sodium ascorbate: Sodium warning recommended by the OTC VMH Panel. |
| 150110 | Hoffman-LaRoche, Inc. | Critical review of OTC Panel addendum to Vitamin C review P. 5 under “B. Kidney or Bladder Stones”. |
| 150111 | Eastman Chemical Products, Inc. | Supplemental submission on data and views of vitamin E. |
| 150112 | Hoffman-LaRoache, Inc. | Summary data on multi-vitamins |
| 150113 | Hoffman-LaRoache, Inc. | Supplemental submission on “High Vitamin Dose Levels in Man”. |
|
150114 150114A 150114B |
Covington & Burling | Statement regarding safety of self-administered iron preparations. |
| 150115 | Linus Pauling Institute of Science & Medicine | Pertinent research articles |
| 150116 | Wilmer, Cutler & Pickering | Memorandum - 3 copies to this office submitted on behalf of the council for Responsible Nutrition |
| 150117 | Hoffman-LaRoche, Inc. | Vitamin items |
| 150118 | Marion Laboratories, Inc. | Oyster shells, OS-CAL |
| 150119 | Marion Laboratories, Inc. | OS-CAL Tabs and Calcium carbonate |
| 150120 | Merrell-National Laboratories | Simron: Elem iron 10mg |
| 150121 | OTC Volume-collection of unpublished data | |
| 150122 | Marion Laboratories, Inc. | OS-CAL tablets, calcium 250mg ergocalciferol (125 USP units) |
| 150123 | Hoffman-LaRoche, Inc. | OTC Vitamin, and Hematinic Products (Vitamin A, B12, C, E, K, biotin) |
| 150123A | Hoffman-LaRoche, Inc. | Biotin |
| 150123B | Hoffman-LaRoche, Inc. | Vitamin E |
| 150124 | Hoffman-LaRoche, Inc. | OTC Vitamin, Mineral, and Hematinic Products |
| 150125 | FDA | OTC Drug Literature Program Part I thru VI, October 15, 1973 |
| 150126 | Philadelphia Dry Yeast Co. | Debittered Brewers Dry Yeast |
| 150127 | The Proprietary Association | Draft Report Number 8 |
| 150128 | ICI Americas, Inc. | Calcium sulfate as a source of calcium |
| 150129 | Marion Laboratories, Inc. | Calcium carbonate, OS-CAL |
| 150130 | FDA |
OTC Drug Literature Program Part I. Vitamins, General December 10, 1973 |
| 150131 | FDA | OTC Drug Literature Part II. Vitamins A,D,E |
| 150132 | FDA |
OTC Drug Literature Program Part III. Pages 1-300 A. Cyanocobalamin B. Folic Acid C. Niacin D. Pantothenic Acid E. Pyridoxine HCL F. Riboflavin G. Thiamine HCL H. Vitamin B Complex |
| 150133 | FDA |
OTC Drug Literature Program Part III. Pages 301-600 |
| 150134 | FDA |
OTC Drug Literature Program Part III. Pages 601-865 |
| 150135 | FDA |
OTC Drug Literature Program Part IV. Ascorbic Acid |
| 150136 | FDA |
OTC Drug Literature Program Part V. Biotin, Choline, Inositol |
| 150137 | FDA |
OTC Drug Literature Program Part VI. Hematinics, Minerals. A. Calcium Salts B. Copper Salts C. Iodine D. Iron Salts E. Magnesium Salts F. Phosphorus Salts G. Zinc Salts |
| 150138 | FDA |
OTC Drug Literature Part I thru VI. January 11, 1974 |
| 150139 | FDA | Index of Submissions and Ingredients to VMH Panel (Breakdown of the volumes by product and Ingredients) |
| Volume | Contents |
|---|---|
| 150140 | A |
| 150141 | Ba - B1 |
| 150142 | Bm - Bz |
| 150143 | Ca – Cn |
| 150144 | Co – Cz |
| 150145 | D |
| 150146 | E |
| 150147 | F |
| 150148 | G |
| 150149 | H – Ha |
| 150150 | Hb – Hz |
| 150151 | I – J |
| 150152 | K |
| 150153 | L |
| 150154 | Ma – Mc |
| 150155 | Me – Mz |
| 150156 | N |
| 150157 | O |
| 150158 | P |
| 150159 | Ra – Ri |
| 150160 | Rj – Rz |
| 150161 | Sa – Sc |
| 150162 | Sd – Sl |
| 150163 | Sm – Sz |
| 150164 | T |
| 150165 | U – V |
| 150166 | W |
| 150167 | X – Z |
| 150168 | A – B |
| 150169 | C – Z |
| 150PA1 |
Panel Administrator’s File (Correspondence File), Volume 1 Contents 1.0 Table of Contents 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Members 1.4 General and Specific Charges 1.5 Summary Minutes 1.6 Interim Report 1.7 List if Panel Submissions 1.8 Regulatory Analysis Assessment 1.9 Statement of Exemption and Environmental Assessment Reports |
| 150PA2 | Panel Administrator’s File ( Correspondence File), Volume II (1972 – 1973) |
| 150PA3 | Panel Administrator’s File (Correspondence File), Volume III (1974) |
| 150PA4 | Panel Administrator’s File ( Correspondence File), |
| 150PA5 | Panel Administrator’s File (Correspondence File), Volume V (1976) |
| 150PA6 | Panel Administrator’s File (Correspondence File), Volume VI (1977) |
| 150PA7 | Panel Administrator’s File (Correspondence File), Volume VII (1978) |
