federal_register: 2023-27015

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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
2023-27015 Bayer HealthCare Pharmaceuticals Inc., et al.; Withdrawal of Approval of CIPRO (Ciprofloxacin Hydrochloride) Oral Tablet, Equivalent to 100 Milligrams Base, and Five Generic Ciprofloxacin Hydrochloride, Oral Tablet, Equivalent to 100 Milligrams Base Drug Products Notice The Food and Drug Administration (FDA or the Agency) is withdrawing the approval of CIPRO (ciprofloxacin hydrochloride (HCl)) oral tablet, equivalent to (EQ) 100 milligrams (mg) base under new drug application (NDA) 019537 and five generic ciprofloxacin HCl, oral tablet, EQ 100 mg base products which referenced it as their basis of submission. The holders of the applications requested withdrawal of the 100 mg strength products and waived their opportunity for a hearing. 2023-12-08 2023 12 https://www.federalregister.gov/documents/2023/12/08/2023-27015/bayer-healthcare-pharmaceuticals-inc-et-al-withdrawal-of-approval-of-cipro-ciprofloxacin https://www.govinfo.gov/content/pkg/FR-2023-12-08/pdf/2023-27015.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is withdrawing the approval of CIPRO (ciprofloxacin hydrochloride (HCl)) oral tablet, equivalent to (EQ) 100 milligrams (mg) base under new drug application (NDA) 019537 and five generic...  

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