federal_register: E5-7646
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E5-7646 | Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs | Proposed Rule | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II) status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products. | 2005-12-22 | 2005 | 12 | https://www.federalregister.gov/documents/2005/12/22/E5-7646/phenylpropanolamine-containing-drug-products-for-over-the-counter-human-use-tentative-final | https://www.govinfo.gov/content/pkg/FR-2005-12-22/pdf/E5-7646.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for over-the-counter (OTC) nasal decongestant and weight control drug products containing phenylpropanolamine preparations. This proposed rule reclassifies... |