federal_register: 99-9770

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
99-9770 Certain Single-Entity Coronary Vasodilators Containing Controlled-Release Nitroglycerin; Opportunity for a Hearing Notice The Food and Drug Administration (FDA) is proposing to withdraw approval of 23 new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing controlled-release nitroglycerin. FDA is offering the holders of the applications an opportunity for a hearing on the proposal. The basis for the proposal is that the sponsors of these products have failed to submit acceptable data on bioavailability and bioequivalence. 1999-04-20 1999 4 https://www.federalregister.gov/documents/1999/04/20/99-9770/certain-single-entity-coronary-vasodilators-containing-controlled-release-nitroglycerin-opportunity https://www.govinfo.gov/content/pkg/FR-1999-04-20/pdf/99-9770.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to withdraw approval of 23 new drug applications (NDA's) and abbreviated new drug applications (ANDA's) for certain single-entity coronary vasodilator drug products containing controlled-release...  

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