federal_register: 2016-08888

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2016-08888 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period Proposed Rule The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter monograph. FDA is reopening the comment period to permit time for additional comments. 2016-04-18 2016 4 https://www.federalregister.gov/documents/2016/04/18/2016-08888/fixed-combination-and-co-packaged-drugs-applications-for-approval-and-combinations-of-active https://www.govinfo.gov/content/pkg/FR-2016-04-18/pdf/2016-08888.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the Federal Register of December 23, 2015 (80 FR 79776), revising its regulations on prescription and nonprescription fixed-combination and...

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