federal_register: 2017-15003

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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
2017-15003 Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications; Correction Notice The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug applications (ANDAs) from multiple applicants, effective November 3, 2016. The document inadvertently announced withdrawal of approval for the following two ANDAs: ANDA 074123 for Pindolol Tablets, held by G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080; and ANDA 080828 for Hydrocortisone Acetate Ophthalmic Ointment USP, held by Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. FDA confirms that the approval of ANDAs 074123 and 080828 is still in effect. 2017-07-18 2017 7 https://www.federalregister.gov/documents/2017/07/18/2017-15003/hospira-inc-et-al-withdrawal-of-approval-of-44-new-drug-applications-and-158-abbreviated-new-drug https://www.govinfo.gov/content/pkg/FR-2017-07-18/pdf/2017-15003.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of October 4, 2016 (81 FR 68427). The document announced the withdrawal of approval of 44 new drug applications and 158 abbreviated new drug...  

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