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U.S. Department of Health and Human Services

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OPDP Form FDA-2253 submissions

According to 21 CFR 314.81(b)(3)(i), all advertisements and promotional labeling for a particular drug product must be submitted at the time of initial publication or dissemination.  Each submission is required to be accompanied by a completed transmittal Form FDA-2253.  Please submit professional and consumer materials separately.  Please do NOT include a cover letter.  All materials, both paper and electronic format, must be submitted in duplicate.  Please be sure to use the most current version of Form FDA-2253 and carefully read the submission instructions:

When submitting Form FDA-2253, please note the following: