Regulatory Information
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OTC Panel Submission (Indices Only): 10 - Ophthalmic
Ophthalmic Administrative File
OTC Ophthalmic Drug Products
(Docket No. 80N-0145)
| VOLUME | SUBMITTED BY | TRADE NAME/SUBJECT |
|---|---|---|
| 100001 | Flow Pharmaceuticals, Inc. | Hy-Flow, aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol |
| 100002 | Riker Laboratories, Inc. | Bro-Lac, Op-Isophrin, Wet-Tone |
| 100003 | Julius Schmid, Inc. | Eyegenic Eye Mist |
|
100004 100005 |
Julius Schmid, Inc. | Eye-Gene Eye Drops |
| 100006 | Abbott Laboratories | Murine |
| 100007 | Burton, Parsons & Company, Inc. | Adsorbonac 2% |
| 100008 | Burton , parsons & Company, Inc. | Adsorbonac 5% |
| 100009 | Burton , parsons & Company, Inc. | Soothe |
|
100011 100012 |
Norwich Pharmacal Company |
Ocusol Eye Lotion, Ocusol eye Drops |
| 100013 | Wyeth Laboratories, Inc. | Collyrium Soothing eye Lotion, Collyrium with Ephedrine Soothing Eye Drops |
| 100014 | Professional Pharmacal Company | Bufopto Zinc Sulfate |
| 100015 | Professional Pharmacal Company | Efricel 1/8% |
| 100016 | Professional Pharmacal Company | Neozin |
| 100017 | Professional Pharmacal Company | Methulose, Visculose |
| 100018 | Barnes-Hind Pharmaceuticals, Inc. | Degest |
| 100019 | Pfizer Pharmaceuticals | Visine Eye Drops |
| 100020 | Alcon Laboratories, Inc. | Contique Contact Lens Wetting Solution, Lens-Mate |
| 100021 | Alcon Laboratories, Inc. | Isopto Frin |
| 100022 | Alcon Laboratories, Inc. | Naphcon |
| 100023 | Alcon Laboratories, Inc. | Op-Thal-Zin |
| 100027 | Alcon Laboratories, Inc. | Contique Artificial Tears |
| 100030 | Alcon Laboratories, Inc. | Zincfrin |
| 100031 | Alcon Laboratories, Inc. | Estivin |
| 100032 | Alcon Laboratories, Inc. | Isopto Tears, Ultra Tears |
| 100033 | Alcon Laboratories, Inc. | Eye-Stream |
| 100034 |
LaWall & Harrisson Research laboratories, Inc. |
20/20 Eye Drops |
|
100035 100036 |
Abbott Laboratories | Clear Eyes |
|
100037 100038 100039 |
Cooper Laboratories, Inc. |
Argyrol S.S., Goniosol, M-Z, Phenylzin, Tear-Efrin, Tearisol |
| 100040 | Allergan Pharmaceuticals | Lacril |
| 100041 | Allergan Pharmaceuticals | Lacri-Lube S.O.P. |
| 100043 | Commerce Drug Company, Inc. | Ocu-Drop |
| 100044 | Commerce Drug Company, Inc. | Stye |
| 100045 | Commerce Drug Company, Inc. | Ocu-Bath |
| 100046 | Alcon Laboratories, Inc. |
Contique Artifical Tears Additional Data |
| 100047 | Allergan Pharmaceuticals | Pre-Sert |
| 100048 | Abbott Laboratories |
murine Additional Data |
| 100050 | Alcon Laboratories, Inc. | Contique Dual-Wet Solution |
| 100051 | Alcon Laboratories, Inc. | Lens-Mate |
| 100052 | Alcon Laboratories, Inc. | Tears naturale’ |
|
100053 100054 |
Mitchum-Thayer, Inc. | Mitchum’s Eye Drops |
| 100055 | Proprietary Association | Test Method Used for All Purpose Contact Lens Solutions |
| 100056 | Allergan Pharmaceuticals | Total |
| 100057 | Schering Corporation |
Documentation in Support of Methylparaben and Propylparaben Comination Documentation in Support of Sodium Thiosulfate Documentation in Support of Tyloxapol |
| 100058 | Alcon Laboratories, Inc. | General Guidelines Applicable to the Evaluation of Lens Care Products |
| 100059 | Allergan Pharmaceuticals | Blink-N-Clean |
| 100060 | Allergan Pharmaceuticals | Liquifilm |
| 100061 | Allergan Pharmaceuticals | Liquifilm Tears |
| 100062 | Allergan Pharmaceuticals | Prefrin Liquifilm Eye Drops |
| 100063 | Allergan Pharmaceuticals | Prefrin-Z Liquifilm |
| 100066 | Allergan Pharmaceuticals | Comments and Recommendations on Panel’s Summary Minutes |
| 100067 | Alcon Laboratories, Inc. | Comments and Recommendations on Panels’s Summary Minutes |
| 100068 | Alcon Laboratories, Inc. | Additional Comments on Cleaning and Wetting Agents |
|
100069 100070 100071 |
Flow Pharmaceuticals |
hy-Flow, aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol Additional data |
| 100072 | Schering Corporation | Comment on 10% Sulfacetamide and 2.3% Sodium Chloride Solution |
| 100073 | Alcon Laboratories, Inc. | Supplemental Data on Cleaning and Wetting Agents |
| 100074 | Alcon Laboratories, Inc. | Additional Studies Regarding Benzalkonium Chloride |
| 100075 | Allergan Pharmaceuticals | Comments on Warnings and Labeling |
| 100076 | Allergan Pharmaceuticals | Additional Information on “Preservative information” |
| 100078 | Norcliff Thayer, Inc. | Safety Protocol for 0.05% Naphazoline |
| 100079 | K.C. Tsou, Ph.D. University of Pennsylvania | Cytochemical Methods |
| 100080 | Allergan Pharmaceuticals | Data on “Draize” Testing Ethylene Oxide Testing, and Buffering |
| 100081 | Alcon Laboratories, Inc. |
Estivin Additional Data |
| 100082 |
Woody D. Davis, M.D. Meridian , Mississippi |
Letter to Panel on Stye Ointment |
| 100083 | Norwich Pharmacal Co. | Supplemental Information on Ocusol Eye Lotion and Comment on Eye Wash and Eye Lotion |
| 100084 | Flow Pharmaceuticals | Clerz |
| 100085 | Alcon Laboratories, Inc. | Supplemental Information on Hydroxypropylmethyl-cellulose |
| 100086 | U.S.V. Pharmaceutical Corp. | Supplemental Information on 0.05% Naphazoline |
| 100087 | Allergan Pharmaceuticals | Methodology for testing Safety, Effectiveness of Hard Contact Lenses. Data for Polyethylene glycol, Polyoxylstearate, Polysorbate. Volumes 1 and 2 |
| 100088 | Alcon Laboratories, Inc. | Benzalkonium Chloride as a Preservative |
|
100089 100090 100091 100092 100093 |
Schering Corporation | Sulffacetamide Data |
| 100094 | U.S.V. Pharmaceutical Corp. | Naphazoline Data: Dr. S. Morgan, Galin, U.S.V. Letter October 21, 1975 |
| 100095 | Allergan Pharmaceuticals | Polyvinyl Alcohol Data on Effectiveness as Wetting Agent |
| 100096 | Ketchum Laboratories | Comments on Preservative Test Guidelines |
| 100097 | Calvin Hanna | Data on 0.05% Naphazoline |
| 100098 | Allergan Pharmaceuticals | Data on the use of Sodium Citrate in Lacril and Liquidifilm Forte |
| 100099 | Alcon Laboratories, Inc. |
Estivin Additional Data |
| 100100 | Alcon Laboratories, Inc. | Collaborative Industry Study on the Effect of Serum on the Preservative Effectiveness of Hard Contact Lens Solutions |
| 100101 |
Woody D. Davis, M.D. Meridian , Mississippi |
Transcript of Presentation to Panel on Stye Ointment |
| 101102 | Proprietary Association | Statement on FDA Policy on Exclususivity of Labeling Terms |
| 100103 | Cooper Laboratories, Inc. | Recommendation to the Panel to Allow Flexibility to Adjust Osmolarity for Ophthalmic Products and Expansion of the List of Acceptable Polyethylene Glycols |
| 100104 | Sherman Laboratories, Inc. | Aqueo-Rinse, Dual-Clean Pena-Vel, Stay-Brite, Stay-Wet, Velva-Kleer |
| 100105 | Commerce Drug Company, Inc. | Study on the Safety and Efficacy of Mercuric Oxide Ointment for Relief of Sties and Minor Infections of the Eyelids |
| 100106 | Proprietary Association | Comments and Recommendations on Panel’s Report |
| 100107 | Medical Library | OTC Drug Literature Program - Ophthalmic Preparations |
| 100108 | Cooper Laboratories, Inc. | Additional Information on Mild Silver Protein as an Anti-infective |
| 100109 | Cooper Laboratories, Inc. | Comments on Panel’s Summary Minutes |
| 100110 | Cooper Laboratories, Inc. | Polyethylene Glycol Additional Information |
| 100111 | William H. Havener, M.D. | Comments on Madatory OTC Drug Labeling |
Public Administrative File
OTC Ophthalmic Drug Products
(Docket No. 80N-0145)
Alphabetical Listing of
References Cited in Report
| VOLUME | CONTENTS |
|---|---|
| 100112 | A - B |
| 100113 | C - D |
| 100114 | E - G |
| 100115 | H - J |
| 100116 | K - M |
| 100117 | N - R |
| 100118 | O: “Ophthalmology Prescription Handbook” (only) |
| 100119 | S |
| 100120 | T - Z |
| 100121 | Miscellaneous Uncited References: A - E |
| 100122 | Miscellaneous Uncited References: F - H |
| 100123 | Miscellaneous Uncited References: I - R |
| 100124 | Uncited References: S: Smith, R.B. editor, “Anesthesia in Ophthalmology” (only) |
| 100125 | Miscellaneous Uncited References: S - Z |
Administrative File
OTC Ophthalmic Drug Products
Docket No. 80N-0145
Panel Administrator’s File
| VOLUME | CONTENTS |
|---|---|
| 10APA1 |
Panel Administrator’s File, Volume I - General 1.1 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 General and Specific Charge to Panel 1.5 Index to Panel Submissions 1.6 Regulatory Analysis Assessment |
| 10APA2 |
Panel Administrator’s File, Volume II - Minutes of Panel Meetings. |
| 10APA3 |
Panel Administrator’s File, Volume III - Correspondence File, (1973-1980). |
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