federal_register: 98-29049

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
98-29049 Eli Lilly & Co. and Bristol-Myers Squibb Co.; Withdrawal of Approval of Three New Drug Applications for Estrogen-Androgen Combination Drugs Notice The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDA's) for estrogen-androgen combination drugs. The NDA's are held by Eli Lilly & Co. and Bristol- Myers Squibb Co. The products are no longer marketed. Both companies requested that the NDA's be withdrawn and waived their opportunity for a hearing. The products will be removed from the list of drug products with effective approvals. 1998-10-29 1998 10 https://www.federalregister.gov/documents/1998/10/29/98-29049/eli-lilly-and-co-and-bristol-myers-squibb-co-withdrawal-of-approval-of-three-new-drug-applications https://www.govinfo.gov/content/pkg/FR-1998-10-29/pdf/98-29049.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDA's) for estrogen-androgen combination drugs. The NDA's are held by Eli Lilly & Co. and Bristol- Myers Squibb Co. The products are no longer marketed. Both...

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