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66 To determine if there are grounds to withdraw or temporarily suspend a PMTA order, FDA can require by regulation, or on an application-by-application basis, that applicants establish and maintain records, and provide postmarket surveillance reports to FDA following PMTA marketing authorization

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How Nicotine Patches Work When a person stops smoking, the body experiences nicotine withdrawal symptoms such as: Irritability Anxiety Cravings Difficulty concentrating Mood swings Restlessness Nicotine patches help by supplying a measured dose of nicotine, reducing the intensity of these symptoms

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