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Drugs

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Labeling

Below is a sortable listing of Labeling Guidances:

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Category	Title	Type	Date
Labeling	Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 52KB)	Final Guidance	01/18/06
Labeling	Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format (PDF - 144KB)	Draft Guidance	03/03/09
Labeling	Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 127KB)	Final Guidance	01/18/06
Labeling	Content and Format for Geriatric Labeling (PDF - 38KB)	Final Guidance	10/01/01
Labeling	Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)	Final Guidance	02/05/10
Labeling	Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products (PDF - 163KB)	Final Guidance	03/22/10
Labeling	Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 147KB)	Final Guidance	03/14/11
Labeling	Labeling for Combined Oral Contraceptives (PDF - 92KB)	Draft Guidance	03/05/04
Labeling	Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 65KB)	Final Guidance	10/16/09
Labeling	Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements (PDF - 213KB)	Draft Guidance	01/24/06
Labeling	Noncontraceptive Estrogen Drug Products for the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms--Recommended Prescribing Informtion for Health Care Providers and Patient Labeling (PDF - 458KB)	Draft Guidance	11/16/05
Labeling	Public Availability of Labeling Changes in "Changes Being Effected" Supplements (PDF - 26KB)	Draft Guidance	09/20/06
Labeling	Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications (PDF - 32KB)	Draft Guidance	10/26/00
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
Labeling	Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices (final) (PDF - 208KB)	Final Guidance	06/26/09
Labeling	Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF - 102KB)	Final Guidance	10/11/11

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