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  • A submission that contains additional information for the Agency to consider following the issuance of an action communication to the applicant (e.g., complete response or inactivation). For promotional labeling and advertising, the submission of revised promotional materials that were previously submitted as an original submission sub-type. Includes requests for advisory on launch materials, requests for advisory on non-launch materials, pre-submission of promotional materials for accelerated approval products, and materials submitted pursuant to 503B.
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Metadata

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Anon_1   (more)
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