federal_register: 04-7533

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
04-7533 Guidance for Industry on Changes to an Approved NDA or ANDA; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled "Changes to an Approved NDA or ANDA." The guidance has been revised to conform to the final rule amending the agency's regulations on changes to an approved NDA or ANDA published elsewhere in this issue of the Federal Register. The guidance is intended to assist applicants in determining how they should report changes to an approved new drug application (NDA) or an abbreviated new drug application (ANDA). 2004-04-08 2004 4 https://www.federalregister.gov/documents/2004/04/08/04-7533/guidance-for-industry-on-changes-to-an-approved-nda-or-anda-availability https://www.govinfo.gov/content/pkg/FR-2004-04-08/pdf/04-7533.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled "Changes to an Approved NDA or ANDA." The guidance has been revised to conform to the final rule amending the agency's regulations on...

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