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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  Orange Flavored Tablets

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 &  E Perles

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  Co. 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)

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