federal_register: 2018-02926
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-02926 | 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 erroneously included abbreviated new drug application (ANDA) 075726 for Pemoline Tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Mallinkrodt Pharmaceuticals, LLC. This notice corrects that error. | 2018-02-13 | 2018 | 2 | https://www.federalregister.gov/documents/2018/02/13/2018-02926/hospira-inc-et-al-withdrawal-of-approval-of-44-new-drug-applications-and-158-abbreviated-new-drug | https://www.govinfo.gov/content/pkg/FR-2018-02-13/pdf/2018-02926.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... |