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Regulatory Information
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OTC Panel Submissions (Indices Only): 12 - Hemorrhoidal (Anorectal)
| VOLUME | SUBMITTED BY | SUBJECT |
|---|---|---|
| 120001 | Upjohn | Tanicaine Rectal Ointment and Suppositories |
| 120002 | Upjohn | Epinephricaine |
| 120003 | Astra | Xylocaine 2.5% & 5% Ointment |
| 120004 | Warner-Chilcott | Anusol Suppositories and Ointment |
| 120005 | Resinol Chemical Company | Resinol Greaseless Cream |
| 120006 | Wyeth Labs | Wyanoids Suppositories Wyanoid Ointment Protegel |
| 120007 | Whitehall | Preparation H Ointment and Suppositories Volume I |
| 120008 | Whitehall | Preparation H Ointment and Suppositories Volume II |
| 120009 | Whitehall | Preparation H Ointment and Suppositories Volume III |
| 120010 | Ciba-Geigy | Nupercainal Ointment and Suppositories Volume I |
| 120011 | Ciba-Geigy | Nupercainal Ointment and Suppositories Volume II |
| 120012 | Chesebrough-Pond’s | Vaseline |
| 120013 |
Sterling Drug Winthrop Labs. Div |
Pontocaine Cream and Ointment Volume I |
| 120014 |
Sterling Drug Winthrop Labs. Div. |
PNS Suppositories Volume II |
| 120015 | Abbott | Tronothane |
| 120016 | Combe | Lanacane Creme |
| 120017 |
Quist Chemical Phenex |
Quist Ointment Phenex Rectal Suppositories |
| 120018 | Combe | Lanacane Creme |
| 120019 | Fuller | Tucks |
| 120020 | Pfizer | Benzyl Alcohol |
| 120021 | Whitehall | Live Yeast Cell Derivative |
| 120022 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120023 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120024 |
Sterling Drug Winthrop Labs. Div. |
PNS Suppositories |
| 120025 | Merrell-National | Diothane Ointment |
| 120026 | Sterling Drug | Tyloxapol |
| 120027 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120028 | Sterling Drug | PNS Suppositories |
| 120029 | Dow Chemical | Dyclone Creme |
| 120030 |
Dr. Kade Pharmazeutische |
Posterisan |
| 120031 | Bristol-Myers | Pazo Ointment and Suppositories |
| 120032 | Whitehall | Skin Respiratory Factor |
| 120033 | Fuller | Tucks |
| 120034 | Humphreys | Hamamelis Water |
| 120035 | Bristol-Myers | Medicated Anal Wipe Foam |
| 120036 |
Dr. Kade Pharmazeutische |
Posterisan |
| 120037 | Bristol-Myers | Aerosol Medicated Anal Wipe Foam |
| Combe | Resorcinol | |
| 120039 | Reed & Carnrick | Non-Steroid Proctofoam |
| 120040 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120041 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120042 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120043 | Phenex | Phenex |
| 120044 | Combe | Resorcinol |
| 120045 | Bristol-Myers | Combination Policy Remarks |
| 120046 | Philips-Roxane | Gentz Wipes |
| 120047 | Combe | Lanacane Creme |
| 120048 | Combe | Resorcinol |
| 120049 | Combe | Resorcinol |
| 120050 | Reed & Carnrick | Non-Steroid Proctofoam |
| 120051 | Various Sources | Unpublished References |
| 120052 | Chesebrough-Pond’s | Vaseline |
| 120053 |
Bellwood Pharmaceutical |
Hemozone |
| 120054 | University of Nebraska Medical Center | Camphor |
| 120055 | Astra | Xylocaine Ointment |
| 120056 | Proprietary Association | Criteria For Placing Category III Ingredients in Category I |
| 120057 | Schwarting |
Lappa/Leptandra Collinsonia |
| 120058 | Proprietary Association | Combination Policy Statement |
| 120059 | Dow Chemical | Dyclone Creme 1% |
| 120060 | Whitehall | Skin Respiratory Factor |
| 120061 | Dr. Trunkey | Donor Site Wound Study |
| 120062 | American Home Products | Skin Respiratory Factor |
| 120063 | Chesebrough-Pond’s | Vaseline |
| 120064 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120065 | Reed & Carnrick | Non-Steroid Proctofoam |
| 120066 | Warner-Chilcott | Anusol Suppositories |
| 120067 | Malmstrom Chemicals | Lanolin and its Derivatives |
| 120068 | Merrell-National | Diothane Ointment |
| 120069 | American Home Products | Skin Respiratory Factor |
| 120070 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120071 | Ciba- Geigy | Nupercainal Ointment Protocol |
| 120072 | Arnar-Stone | Benzocaine |
| 120073 | Merrell-National | Diothane Ointment/NDA 1-941 |
| 120074 | Proprietary Association | Combination & Testing Policies Comments |
| 120075 | Merrell-National | Diothane Ointment |
| 120076 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120077 | Ciba-Geigy | Nupercainal Ointment and Suppositories |
| 120078 | Ciba-Geigy | Nupercainal Ointment |
| 120079 | Schuylkill Chemical | Allantoin & Alcloxa |
| 120080 | Proprietary Association | Comments on Panel’s Draft Report Released December 1977 |
| 120081 | Ciba-Geigy | Nupercainal Suppositories |
| 120082 | Whitehall | Skin Respiratory Factor |
| 120083 | Whitehall | Miscellaneous Hemorrhoidal Product Labeling |
| 120084 | Abbott | Tronothane Cream & Jelly |
| 120085 | Merrell-National | Diothane Ointment Volume I |
| 120086 | Merrell-National | Diothane Ointment Volume II |
| 120087 | Proprietary Association |
Combination & Testing Policies (Same as Volume 120074) |
| 120088 | Astro-Solar | Tengum |
| 120089 | Boston University | Nupercainal Ointment and Suppositories |
| 120090 | Ciba-Geigy | Transcript of 5/3/75 Meeting |
| 120091 | Chesebrough-Pond’s | Corrections of Summary Minutes of 27th Meeting of Hemorrhoidal Panel |
| 120092 | Whitehall | Skin Respiratory Factor Presentation |
| 120093 |
Skin Respiratory Factor Presentation (References) |
Alphabetical Listing of
References Not Cited in Report
| VOLUME | CONTENTS |
| 120103 | A-B |
| 120104 | C-D |
| 120105 | E-G |
| 120106 | H-K |
| 120107 | L-O |
| 120108 | P-Z |
ADMINISTRATIVE FILE
OTC Anorectal Drug Products
Docket No. 80N-0050
PUBLIC ADMINISTRATOR’S FILE
| VOLUME | CONTENTS |
|---|---|
| 12APA1 |
Panel Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Memebers and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Report |
| 12APA2 | Panel Administrator’s File, Volume II - Minutes of Panel Meetings. |
| 12APA3 | Panel Administrator’s File, Volume III - Correspondence File (1972-1980) |
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