The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA Submissions--Content and Format.'' This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug and Cosmetic Act (the FD&C Act).
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Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``ANDA Submissions--Content and Format.'' This guidance...
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83 FR 48432
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“Abbreviated New Drug Application Submissions-Content and Format; Guidance for Industry; Availability,” thefederalregister.org (September 25, 2018), https://thefederalregister.org/documents/2018-20790/abbreviated-new-drug-application-submissions-content-and-format-guidance-for-industry-availability.