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Drugs

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Labeling

Title and Format	Type	Issue Date
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format	Final	1/18/2006
Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format	Draft	3/3/2009
Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format	Final	1/18/2006
Content and Format for Geriatric Labeling	Final	10/2001
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products	Draft	4/6/2007
Contents of a Complete Submission for the Evaluation of Proprietary Names	Draft	11/24/2008
Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims	Draft	3/12/2008
Labeling for Combined Oral Contraceptives	Draft	3/2/2004
Labeling for Human Prescription Drugs -- Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (PDF - 66 KB)	Final	10/16/2009
Labeling for Human Prescription Drug and Biological Products — Implementing the New Content and Format Requirements	Draft	1/18/2006
Labeling Guidance for OTC Topical Drug Products for the Treatment of Vaginal Yeast Infections (Vulvovaginal Candidiasis)	Draft	6/1998
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	Draft	11/15/2005
Public Availability of Labeling Changes in "Changes Being Effected" Supplements	Draft	9/19/2006
Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications	Draft	10/26/2000
Updating Labeling for Susceptibility Test Information in Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices	Final	6/26/2009
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format	Draft	1/18/2006

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