Regulatory Information
OTC Panel Submissions (Indices Only): 05 - Sleep-Aids
OTC Sedatives, Tranquilizers and Sleep Aids Review Panel Index to Data Submissions
| Volume | Submitted By | Trade Name | Ingredients | Remarks |
|---|---|---|---|---|
| 050001 | Monsanto Co. | None |
Methapyrilene HCl Methapyrilene Fumarate |
Bulk Chemical Bulk Chemical |
| 050002 | FDA (Portland Retail Druggist Association) | None | Miscellaneous Documents from FDA files - Originally Submitted to DESI Study | |
|
050003 (Box A) |
J. B. Williams Co. | Sominex Tablets |
Scopolamine Aminoxide HBr. Methapyrilene HCl Salicylamide |
Submitted loose in boxes at Firms request |
|
050004 (Box B) |
Sominex Tablets |
Scopolamine Aminoxide Hbr Methapyrilene Hcl Salicylamide |
||
| 050005 | Whitehall Labs. Inc. | Quiet World |
Acetaminophen Aspirin Methapyrilene Hcl Scopolamine Hbr. |
|
| 050006 | Whitehall Labs. | Sleep-eze |
Methapyrilene HCl Scopolamine HBr |
|
| 050007 | Block Drug Co. |
Nytol Tablets Nytol Capsules |
Methapyrilene HCl Scopolamine HBr Methapyrilene HCl Salicylamide |
|
|
050008 050009 |
Jeffrey Martin Inc. | Compoz Tablets |
Pyrilamine maleate Methapyrilene HCl Scopolamine aminoxide HBr. |
|
| 050010 | FDA (Dr. Chernov) | Selected articles and papers | ||
| 050011 | FDA (Medical Library) | FDA Library Search Abstracts | ||
| 050012 | FDA (OTC Staff) | A Study of Health Practices and Opinions Final Report FDA Contract No. 66-193, June, 1972 | ||
| 050013 | FDA (OTC Staff) | Methapyrilene HCL | Drug Efficacy Study (NAS?NRC) Reports only one drug was covered, DORMIN | |
| 050014 | Miles Labs. | Miles Nervine |
Sodium bromide Potassium bromide Ammonium bromide |
|
| 050016 | FDA (Dr. Chernov) | Scopolamine | Paper titled “Proprietary Hallucinogens” by Leff and Bernstein | |
| 050017 | FDA (Medical Library) | Salicylamide | Limited literature search and bibliography on Salicylamide with selected articles | |
| 050018 | Dr. Hartmann | Selected Papers by Dr. Hartmann submitted to the other Panel members at his request | ||
| 050019 | Jeffrey martin Inc. | Compoz Tablets | Amendment to previous submission (050008) “Appropriate and Inappropriate Methodology in the evaluation of OTC Daytime Sedatives | |
| 050020 | Jeffrey Martin Inc. | Compoz Tablets | (More legible copy of Submission No. 050009) | |
| 050021 | J. B. Williams Co. | Data on sedative properties of DOXYLAMINE and PHENYLTOLOXAMINE | ||
| 050022 | Miles labs. | None |
Diphenhydramine Hydrochloride |
Data on the use of this agent as a sedative-sleep aid |
|
050023 050024 |
Bristol-Myers | Excedrin P.M. |
Aspirin Salicylamide Acetaminophen Methapyrilene furmarate |
|
| 050025 | FDA | Adverse Reactions Data on Bromides, Scopolamino Compoz and Sominex requested by Panel | ||
| 050026 | Miles Labs. | None |
Diphenhydramine Hydrochloride |
Additional data submitted at Panel’s request |
| 050027 | Bristol-Myers | Additional data on Methapyrilene/Excedrin P.M. | ||
| 050028 | Parke Davis |
Bendryl Diphenhybromide |
||
| 050029 | Dr. Norris | Toxicity Data | ||
| 050030 | FDA | Labeling information request by Panel | ||
| 050031 | Endo. Labs. | Percogesic Dilone |
Acetaminophen Phenyltoloxamine acetate Caffeine |
|
| 050032 | Bristol-Myers | Excedrin P.M. | Additional Data | |
| 050033 | Bristol-Myers | Excedrin P.M. | Additional Data | |
| 050034 | Bristol-Myers | Excedrin P.M. |
Additional Submission (Excedrin P.M.) |
|
| 050035 | Parke Davis | Benadryl | ||
| 050036 | Jeffrey Martin | Compoz | Comments on Daytime Sedatives | |
| 050037 | Parke Davis |
Diphenhydramine (Bendryl) |
Additional data | |
| 050038 | Endo Labs. | Additional information on percogesic | ||
| 050039 | Parke Davis | Study plan for Diphenhydramine | ||
| 050040 | J.B. Williams | Additional comments on Dr. Rickels study of Compoz | ||
| 050041 |
Whitehall Labs. Division of American Home Products |
Diphenhydramine | Additional data | |
| 050042 |
Whitehall Labs. Division of American Home Products |
Diphenhydramine | Data requestred by Panel | |
| 050043 | Sedative Panel Working Papers | |||
| 050044 |
Del Labs. Inc. Parmingdale, N.Y. |
Placin Calmative Capsules |
Paminobenzoic Acid Salicylamide Passiflora (Passion Flower) P.E. Euphorbia P.E. |
|
| 050045 |
Johnson and Johnson Co. New Brunswick, N.J. |
Safety data on talc | ||
| 050046 | American Home Products Corp. | Target population for Daytime Sadatives | ||
| 050047 | Lemming-Pacquin | Comments on Doxylamine Succinate | ||
| 050048 | FDA | Hypnotic Testing guidelines | ||
| 050049 | Referenences - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants A-E | |||
| 050050 | References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants F -K | |||
| 050051 | References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants L-R | |||
| 050052 | References - Nighttime Sleep-Aids, Daytime Sedatives, Stimulants S-Z | |||
| 050053 | Scopolamine | References - (uncited) | ||
| 050054 | Scopolamine | References - (uncited) | ||
| 050055 | Miscellaneous | References - (uncited) |
