Guidance for Industry on Labeling Over-the-Counter Human Drug Products--Updating Labeling in Reference Listed Drugs and
Abbreviated New Drug Applications; Availability.
(18OCT02)
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The Guidance |
Ingrown Toenail Relief Drug Products for Over-the-Counter Human Use. (04OCT02)
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Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of the
Tentative Final Monograph, and Related Labeling.
(21AUG02)
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CDER 01185 Sunscreen Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment. (20JUN02)
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Agency Information Collection Activities; Announcement of OMB Approval; Format and Content Requirements for
Over-the-Counter (OTC) Drug Product Labeling.
(15MAY02)
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Supporting Statement |
Pediculicide Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph. (10MAY02)
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Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients addresses the ingredient
octoxynol 9, considered in the rulemaking for OTC vaginal contraceptive drug products. (09MAY02)
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Status of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients concerning stimulant laxative
ingredients aloe (including aloe extract and aloe flower extract) and cascara sagrada (including casanthranol, cascara fluidextract aromatic, cascara sagrada bark, cascara sagrada extract, and cascara sagrada
fluidextract). (09MAY02)
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Over-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates. (05APR02)
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Anticaries Drug Products for Over-the-Counter Human Use; Use of Intraoral Appliance Models for Compliance with Biological
Testing Requirements; Request for Information and Comments; Reopening of Comment Period. (15MAR02)
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Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph ; Correction. (15MAR02)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Format and Content Requirements for
Over-the-Counter (OTC) Drug Product Labeling.
(26FEB02)
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Topical Antifungal Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph. (08FEB02)
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Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and
Effective and Not Misbranded. (23JAN02)
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