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In this section: Postmarket Drug Safety Information for Patients and Providers

Safety Labeling Change Orders

Prozac (fluoxetine) capsules, USP, Safety Labeling Change Order, 6/07/2021
2020 Safety Labeling Change Order Letters - No Letters Issued
2019 Safety Labeling Change Order Letters - No Letters Issued

2011-2018 Letters are in the FDA Archive

Related Information

Safety Labeling Changes -- Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act

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