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OTC Panel Submissions (Indices Only): 17 - Miscellaneous Internal

STOMACH ACIDIFIER ADMINISTRATIVE RECORD
(Docket No.  79N-0176)
Index to Panel Submissions

Volume No. Firm Subject
170011 Stuart Pharmaceuticals Stuart Amino Acids with B12
170023 Winthrop Laboratories Acidol-Pepsin
170049 Dorsey laboratories Kanulase Tablets
170103 Eli Lilly and Company Acidulin (glutamic acid hydrochloride) Volume I
170104 Eli Lilly and Company Acidulin (glutamic acid hydrochloride)  Volume II
170105 Stuart Pharmaceuticals Normacid Supplements
170124 Eli Lilly and Company Acidulin (glutamic acid hydrochloride)

SWEET SPIRITS OF NITRE
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(Docket No.  79N-0177)
INDEX TO PANEL SUBMISSION

Volume No. Contents
170163 1. Letter dated August 30, 1976, to Robert J. Haggerty, M.D., from Joseph P. Hile, Acting Commissioner of Food and Drugs, pertaining to sweet spirits of nitre.
170183 References
170PA1 Panel Administrator’s File

CHOLECYSTOKINETIC DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE
DMINISTRATIVE RECORD
(Docket No.  79N-0368)
INDEX TO PANEL SUBMISSIONS

Volume No. Submitted by Subject
170045 Gray Pharmaceutical Co.

G.B.-Prep Emulsion

(Corn oil)

170184   References
17CPAI   Panel Administrator’s File

ANTHELMINTIC DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(Docket No.  79N-0378)

Volume No. Submitted By Subject
170024 Sterling Drug Company Jayne’s PW Vermifuge
170033 Pfizer Pharmaceuticals Inc. Antiminth Oral Suspension
170068 Pfizer Pharmaceuticals Inc. Pyrantel Pamoate oral Suspension (Vol. 1 of 6)
170069 Pfizer Pharmaceutical Inc. Pyrantel Pamoate Oral Suspension (Vol. 2 of 6)
170070 Pfizer Pharmaceuticals Inc.

Pyrantel Pamoate Oral Suspension

(Vol. 3 of 6)

170071 Pfizer Pharmaceuticals, Inc

Pyrantel Pamoate Oral Suspension

(Vol. 4 of 6)

170072 Pfizer Pharmaceuticals, Inc. Pyrantel Pamoate Oral Suspension (Vol. 5 of 6)
170073 Pfizer Pharmaceuticals, Inc.

Pyrantel Pamoate Oral Suspension

(Vol. 6 of 6)

170101 Scientific Associates inc. Piperazine Citrate Syrup
170122 Pfizer Pharmaceuticals Inc. Pyrantel Pamoate Oral Suspension
170133 Sterling Drug Co. Jayne’s PW Vermifuge
170134 Pfizer Pharmaceuticals Inc. Pyrantel Pamoate Oral Suspension
170158 Pfizer Pharmaceuticals Inc. Pyrantel Pamoate Oral Suspension
170160 Pfizer Pharmaceuticals Inc. Pyrantel Pamoate oral Suspension
170161 Memorandum from the Division of Drug Experience to the Division of OTC Drug Evaluation Adverse Peactions to Antiminth, Povan, Piperazine Citrate, and Gentian Violet
170162 Pfizer Internatonal Drug Experience Report
170207   References
17FPAI   Panel Administrator’s File (1.1 – 1.8)
17FPAII   Panel Administrator’s File (Correspondence)

Exocrine Pancreatic Insufficiency Drug Products
For Over-The-Counter Human Use
Administrative Record
(Docket No.  79N-0379)
Index to Panel Submissions

Volume No. Submitted By Subject
170034 Winthrop Labs. Stamyl tablets
170130 Parke-Davis and Co. Panteric capsules, tablets, granules
170144 Hoechst-Roussel Pharm.  Festal tablets (Volume 1 of 3)
170145 Hoechst-Roussel Pham. Festal tablets (Volume 2 of 3)
170146 Hoechst-Roussel Pharm. Festal tablets (Volume 3 of 3 )
170182   References
17BPAI   Panel Administrator’s File

Hypophosphatemia and Hyperphosphatemia Drug Products For
Over-The-Counter Human Use
Administrative Record
(Docket No.  80N-0395)
Index to Panel Submissions

Volume No. Submitted By Subject
170005 Wyeth Laboratories Inc. Basaljel
170043 Wyeth Laboratories Inc. Phosphaljel
170211   References
17HPAI   Panel Administrator’s File (1.1 – 1.9)

 

Smoking Deterrent Drug Products For
Over-The-Counter Human Use     
Administrative Record
(Docket No.  81N-0027)

Volume No. Submitted By Subject
170001 Health Sciences Association Nicoprive (Volume 1 of 2)
170002 Health Sciences Association Nicoprive (Volume 2 of 2)
170038 Campana Corporation Bantron
170129 Edgefield Corporation Tabmint Chewing Gum
170168 S.A. Cravotta Company “I Quit”
170169 Friend, Perles, Dorfman and Kleefeld Nicocortyl (Volume 1 of 2)
170170 Friend, Perles, Dorfman and Kleefeld Nicocortyl (Volume 2 of 2)
170173 Buffalo District, FDA Nicocortyl
170178 Edgefield Corporation Tabmint Chewing Gum
170229   References
17KPAI   Panel Administrator’s File


Insect Repellent Drug Products for
Over-the-Counter Oral Human Use
Administrative Record
(Docket No. 81N-0040)
Index to Panel Submissions

Volume No. Submitted By Subject
170174 FDA Journal articles and textbook abstracts
17NPAI FDA Panel Administrator’s File (1.1 – 1.8)


Drug Products For Over-the-Counter Human Use
For the Treatment of Acute Toxic Ingestion&
Administrative Record
(Docket No. 81N-0050)
Index to Panel Submission

Volume No. Submitted By Subject
170139 Bowman Pharmaceuticals, Inc. Poison Control Kit
170150 Requa manufacturing Company, Inc. Activated Charcoal
170151 Regua Manufacturing Company, Inc. Activated Charcoal
170227 FDA References (Cited and Uncited)
170PAI FDA Panel Administrator’s File

Orally Administered Drug Products For the Treatment
Of Fever Blisters for Over-the-Counter Human Use
Administrative Record
(Docket No.  81N-0060)
Index to Panel Submissions

Volume No. Submitted By Subject
170052 Hynson, Westcott and Dunning, Inc.  
170180 Hynson, Westcott and Dunning, Inc. Lactinex
170185 Hynson, Westcott and Dunning, Inc. Lactinex
170228   References
17IPAI   Panel Administrator’s File


Deodorant Drug Products for Internal Use for
Over-the-Counter Human Use
Administrative File
(Docket No.  81N-0064)
Index to Panel Submissions

Volume No. Submitted By Subject
170014 Rystan Company Inc. Derifil Tablets Chloresium Tablets Activated Charcoal
170125 Brooklyn-Cumberland Medical Center Activated Charcoal
170151 Requa manufacturing Co., Inc. Activated Charcoal
170171 Parthenon Co. inc. Bismuth Subgallate
170172 Norma Gill, et. Al. “Odor Barriers”
170179 Requa maufacturing Co. Inc. Activated Cahrcoal
170226 FDA References
17PPAI FDA Panel Administrator’s File


Digestive Aid Drug Products For
Over-the-Counter Human Use
Administrative Record
(Docket No.  81N-0106)
Index to Panel Submissions

Volume No. Submitted By Subject
170003 Van Patten Pharmaceutical Co. Alliman Tablets
170006 Chattem, Inc. Cardui Liquid
170017 Requa manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170018 Reed & Carnrick Pharmaceuticals Phazyme Tablets
170019 Reed & Carnrick Pharmaceuticals Phasil Tablets
170020 Reed & Carnrick Pharmaceuticals Laxsil Liquid
170023 Winthrop Products Inc. Acidol-Pepsin Capsules
170034 Winthrop Products Inc. Stamyl Tablets
170042 Purdue Frederick Co. ProBilagol Liquid
170049 Dorsey Laboratories Kanulase Tablets
170053 Lewis_Howe Company Tums and Dicarbosil Tablets
170054 Warner/Chilcott Gelusil Tablets and Liquid
170055 Signet Laboratories Inc. Dihepatone Tablets
170058 Lewis-Howe Company Tums and Dicarbosil Tablets
170059 Warner/Chilcott Gelusil Tablets and Liquid
170061 Warner-Lambert Company Rolaids Tablets
170062 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170063 Warner/Chilcott Gelusil Tablets and Liquid
170065 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170074 Warner-Lambert Company Bromo-Seltzer Granules
170075 Winthrop Products Inc. Stamyl Tablets
170098 Lewis-Howe Company Tums ad Dicarbosil tablets
170100 Carter Products Gastroenterase Tablets
170106 Winthrop Products Inc. Stamyl Tablets
170120 Lewis-Howe Company Tums and Dicarbosil Tablets
170128 Warner-Lambert Company Hydrate Magnesium Aluminate Activated Sulfate Liquid Tablets
170130 Parke-Davis & Co. Panteric Capsules, Tablets and Granules
170131 Reed & Carnrick Pharmaceuticals Phazyme Tablets
170135 Palafox Laboratories, Inc. Palagastra Liquid
170136 Reed & Carnrick Pharmaceuticals Phazyme Tablets
170137 Warner-Lambert Company Rolaids Tablets
170140

Bowman Pharmaceuticals Inc.

The Rilox Company

Father Francis’ Herbs

Controflex Phosphorated Syrup

Brodie’s Cordial Liquid

Medicinal Tea No. 1 & No. 3

170142 Warner-Lambert Company Hydrate Magnesium Aluminate Activated Sulfate Liquid & Tablets
170143 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170144 Hoechst-Roussel Pharmaceuticals Inc. Festal Tablets
170145 Hoechst-Roussel Pharmaceuticals Inc. Festal Tablets
170146 Hoechst-Roussel Pharmaceuticals Inc. Festal Tablets
170151 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170152 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170154 Requa Manufacturing Co., Inc. Activated Charcoal Tablets and Capsules, Charcoal Tablets
170156 Warner-Lambert Company Roliads Tablets
170159 Reed & Carnrick Pharmaceuticals Phazyme Tablets
170230   Cited References A – H
170231   Cited References J – Z
170232   Unicited References
17GPAI  

Panel Administrator’s File

(1.1 – 1.6)

17GPAII  

Panel Administrator’s File

(Correspondence 1973-1981)


ORALLY ADMINISTERED DRUG PRODUCTS FOR RELIEF OF SYMPTOMS
ASSOCIATED WITH OVERINDULGENCE IN ALCOHOL AND FOOD
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO.  82N-0166)
INDEX TO PANEL SUBMISSIONS

OTC Volume No. Submitted By Subject
170015 Schmid Laboratories, Inc. Fructose tablets
170016 Cary Corporation Chaser tablets
170107 Miles Laboratories, Inc. Alka-Seltzer tablets
170108 Miles Laboratories, Inc. Alka-Seltzer tablets
170109 Miles Laboratories, Inc. Alka-Seltzer tablets
170110 Miles Laboratories, Inc. Alka-Seltzer tablets
170111 Miles Laboratories, Inc. Alka-Seltzer tablets
170112 Miles Laboratories, Inc. Alka-Seltzer tablets
170113 Miles Laboratories, Inc. Alka-Seltzer tablets
170114 Miles Laboratories, Inc. Alka-Seltzer tablets
170115 Miles Laboratories, Inc. Alka-Seltzer tablets
170116 Miles Laboratories, Inc. Alka-Seltzer tablets
170117 Miles Laboratories, Inc. Alka-Seltzer tablets
170118 Miles Laboratories, Inc. Alka-Seltzer tablets
170123 Miles Laboratories, Inc. Alka-Seltzer tablets
170132 Miles Laboratories, Inc. Alka-Seltzer tablets
170151 Requa manufacturing Company, Inc. Requa’s Activated Charcoal tablets and capsules
170175 Lemmon Company Quick. Over capsules
170177 Warner-Lambert Company Bromo-Seltzer granules
170181 Requa Manufacturing Company, Inc. Requa’s Activated Charcoal tablets and capsules
170187 Norwich Eaton Pharmaceuticals Pepto-Bismol Liquid
170188 Cary Corporation Chaser tablets
170189 Miles Laboratories, Inc. Alka-Seltzer tablets
170190 Miles Laboratories, Inc. Alka-Seltzer tablets
170191 Miles Laboratories, Inc. Alka-Seltzer tablets
170192 Miles Laboratories, Inc. Alka-Seltzer tablets
170193 Miles Laboratories, Inc. Alka-Seltzer tablets
170194 Miles Laboratories, Inc. Alka-Seltzer tablets
170195 Miles Laboratories, Inc. Alka-Seltzer tablets
170196 Miles Laboratories, Inc. Alka-Seltzer tablets
170197 Miles Laboratories, Inc. Alka-Seltzer tablets
170198 Miles Laboratories, Inc. Alka-Seltzer tablets
170199 Miles Laboratories, Inc. Alka-Seltzer tablets
170200 Miles Laboratories, Inc. Alka-Seltzer tablets
170201 Miles Laboratories, Inc. Alka-Seltzer tablets
170202 Miles Laboratories, Inc. Alka-Seltzer tablets
170203 Miles Laboratories, Inc. Alka Seltzer tablets
170204 Miles Laboratories, Inc. Alka Seltzer tablets
170205 Miles Laboratories, Inc. Alka Seltzer tablets
170206 Norwich Eaton Pharmaceuticals Pepto-Bismol liquid
170208 Norwich Eaton Pharmaceuticals Pepto-Bismol liquid
170212 Miles Laboratories, Inc. Alka-Seltzer tablets
170213 Miles Laboratories, Inc. Alka-Seltzer tablets
170214 Miles Laboratories, Inc. Alka-Seltzer tablets
170220 Schmid Laboratories, Inc. Fructose tablets
170236   Cited References
170237  

Uncited References

(A through I)

170238  

Uncited References

(J through Y)

17LPAI  

Panel Administrator’s File

(Sections 1.1 – 1.6)

17LPAII  

Panel Administrator’s File

(Correspondence 1974 through 1981)


QUININE FOR THE TREATMENT OF NOCTURNAL LEG MUSCLE CRAMPS
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO.  77N-0094)
INDEX TO PANEL SUBMISSIONS 

Volume No. Submitted By Subject
170050 Purex Corporation Quinine sulfate capsules
170234 FDA-Generated Material Miscellaneous Information
17QPAI   Panel Administrator’s File


APHRODISIAC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO.   80N-0419)
INDEX TO PANEL SUBMISSIONS

Volume No. Submitted By Subject
17JPAI   Panel Administrator’s File


DRUG PRODUCTS TO TREAT THE SYMPTOMS

ON BENIGN PROSTATIC HYPERTROPHY
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO.  82N-0168)
INDEX TO PANEL SUBMISSIONS 

Volume No. Submitted By Subject
170233 FDA-Generated material Miscellaneous Information
17RPAI   Panel Administrator’s File


Weight control drug products for
Over-the-Counter Human Use
Administrative Record
(Docket No.  81N-0022)
INDEX TO PANEL SUBMISSIONS

Volume No. Submitted By Subject
170009 Thompson Medical Co., Inc. Appedrine tablets
170010 Thompson Medical C., Inc. Slim-Line candy
170012 Marion Laboratories, Inc. Pretts tablets
170013 Thompson Medical Co., Inc. Slim-Line candy
170028 Fox Pharmacal, Inc. Odrinex tablets
170029 Fox Pharmacal, Inc. Odrinex tablets
170030 Thompson Medical Co., Inc. Prolamine capsules
170037 Thompson Medical Co., inc. Slim-Mint gum
170041 Alleghany Pharmaceutical Corp. Hungrex w/P.P.A. tablets
170044 Marion Laboratories, Inc. Pretts tablets
170047 Thompson Medical Co., Inc. Appedrine tablets
170048 Thompson Medical Co., Inc. Slim-Line candy
170051 Marion Laboratories, Inc. Pretts tablets
170056 Purex Corp. Slendron capsules
170057 Fox Pharmacal, Inc. Odrinex tablets
170060 Thompson Medical Co., Inc. Appedrine tablets
170067 Thompson Medical Co., Inc. Appedrine tablets
170082 Marion Laboratories, Inc. Pretts tablets
170093 Thompson Medical Co., Inc. Slim-Mint gum
170094 Thompson Medical Co., Inc. Slim-Line candy
170096 Thompson Medical Co., Inc. Prolamine capsules
170119 Marion Laboratories, Inc. Pretts tablets
170126 Thompson Medical Co., Inc. Weight Control Information
170127 Thompson MedicalCo., inc. Slim-Mint gum and Slin-Line candy
170141 Marion Laboratories, Inc. Pretts tablets
170147 Fox Pharmacal, Inc. Super-Odrinex tablets
170148 Fox Pharmacal, Inc. Super-Odrinex tablets
170149 Fox Pharmacal, Inc. Super-Odrinex tablets
170153 Fox Pharmacal, Inc. Super-Odrinex tablets
170155 Thompson Medical Co., Inc. Phenylpropanolamine
170164 Fox Pharmacal, Inc. Super-Odrinex tablets
170166 Alleghany pharmaceutical Corp. Permathene-12 capsules
170235   Cited and uncited References
17EPAI  

Panel Administrator’s File

(1.1 – 1.6)

17EPAII  

Panel Administrator’s File

(Correspondence 1975-1977)

17EPAIII  

Panel Administrator’s File

(Correspondence 1977-1982)


ORALLY ADMINISTERED MENSTRUAL DRUG PRODUCTS
FOR OVER-THE-COUNTER HUMAN USE
ADMINISTRATIVE RECORD
(DOCKET NO.  82N-0165) 

Volume No. Submitted By Subject
170004 Whitehall Laboratories, Inc. Trendar tablets
170022 Sterling Drug Inc. Midol tablets
170025 USV Pharmaceutical Corporation Femicin tablets
170026 Chattem, Inc. Neo Bromth tablets
170027 Chattem, Inc. Pamprin tablets, Cardui tablets, and Zodiex tablets
170031 The Emko Company Sunril capsules
170032 Thompson Medical Company, Inc. Aqua-Ban tablets
170046 Thompson Medical Company, Inc. Aqua-Ban tablets
170066 Pfizer Pharmaceuticals Femanol liquid
170076 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable Compound liquid
170077 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable Compound liquid
170078 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable Compound liquid
170079 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable Compound liquid
170080 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable compound liquid
170081 Cooper Laboratories, Inc. Lydia E. Pinkham tablets and Vegetable Compound liquid
170095 Thompson Medical Company, Inc. Aqua-Ben tablets
170097 McNeil Laboatories, inc. Tylenol tablets and Tylenol with Codeine tablets
170121 Pfizer pharmaceuticals Femanol liquid
Chattem, inc. Pamabrom-containing products
170210 Sterling Drug Inc. Midol tablets
170217 Thompson Medical Company, Inc. Aqua-ban tablets
170218 Chattem, Inc. Pyrilamine maleate-menstrual syndrome
170219 Chattem, Inc. Pamprin tablets
170221 Chattem, Inc. Pamabrom/pyrilamine maleate combinations
170222 Sterling drug inc. Midol tablets
170223 Chattem, Inc. Pamabrom/pyrilamine maleate combinations
170224 Chattem, Inc. Pamprin tablets
170225 Sterling Drug Inc. Midol tablets
170239   Cited References (A – H)
170240   Cited References (I – Y)
170241   Uncited References
17MPAI  

Panel Administrator’s File

(1.1 – 1.6)

17MPAII  

Panel Administrator’s File

(Correspondence)

 

 

NO _______IFM___________  VOLUME WAS MADE FOR  ________________________________

 

 

CHOLECYSTOKINETIC DRUG________________________________________________________

 

PRODUCTS ________________________________________________________________

 

TFM VOLUME 17ATFM____________________________

 

Has been established for STOMACH____________________

 

ACIDIFIER_______________________________________

 

 

 

TFM VOLUME 17FTFM_____________________

 

Has been established for ANTHELMINTIE_________________

 

DRUG_PRODUCTS___________________________________

 

 

TFM VOLUME 17HTFM_________________

 

Has been established for HYPOPHOSPHATEMIA_____________

 

AND HYPERPHOSPHATEMIA___________________________

  

 

TFM VOLUME 17JTFM___________________

 

Has been established for APHRODISIAC__________________________

 

DRUG PRODUCTS__________________________________________

 

  

 

TFM VOLUME 17OTFM__________________________

 

Has been established for POISON TREATMENT_________________________