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Drugs

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Over-the-Counter

Below is a sortable table listing the Over-the-Counter Guidances

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Category	Title	Type	Date
Over-the-Counter	Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16). (PDF - 294KB)	Final Guidance	05/01/84
Over-the-Counter	General Guidelines for OTC Combination Products (PDF - 270KB)	Final Guidance	11/01/78
Over-the-Counter	Label Comprehension Studies for Nonprescription Drug Products (PDF - 148KB)	Final Guidance	08/03/10
Over-the-Counter	Labeling OTC Human Drug Products -- Questions and Answers (PDF - 599KB)	Final Guidance	01/02/09
Over-the-Counter	Labeling OTC Human Drug Products -Submitting Requests for Exemptions and Deferrals (PDF - 34KB)	Draft Guidance	12/19/00
Over-the-Counter; Small Entity Compliance Guides	Labeling OTC Human Drug Products; Small Entity Compliance Guide (PDF - 270KB)	Final Guidance	05/12/09
Over-the-Counter	Labeling OTC Human Drug Products Updating Labeling in ANDAs (PDF - 32KB)	Draft Guidance	02/21/01
Over-the-Counter	Labeling OTC Human Drug Products Updating Labeling in RLDs and ANDAs (PDF - 30KB)	Final Guidance	10/01/02
Over-the-Counter	Labeling OTC Human Drug Products Using a Column Format (PDF - 57KB)	Final Guidance	12/01/00
Over-the-Counter; Small Entity Compliance Guides	Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use — Small Entity Compliance Guide (PDF - 176KB)	Final Guidance	08/17/10
Over-the-Counter	Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (PDF - 298KB)	Final Guidance	07/13/09
Over-the-Counter	Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers (PDF - 83KB)	Final Guidance	08/13/09
Over-the-Counter	Time and Extent Applications for Nonprescription Drug Products (PDF - 241KB)	Final Guidance	09/28/11
Labeling; Over-the-Counter; Small Entity Compliance Guides	Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB)	Final Guidance	06/21/11
Over-the-Counter	Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731) (PDF - 583KB)	Final Guidance	10/01/78
Over-the-Counter	Self-Selection Studies for Nonprescription Drug Products (PDF - 160KB)	Final Guidance	04/10/13
Over-the-Counter; Small Entity Compliance Guide	Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide)	Final Guidance	11/14/12
Over-the-counter	Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-The-Counter Human Use — Small Entity Compliance Guide	Final Guidance	12/05/12

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