federal_register: 04-17445
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 04-17445 | Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Final Monograph for Over-the-Counter Nasal Decongestant Drug Products | Proposed Rule | The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies) to remove the indication "for the temporary relief of nasal congestion associated with sinusitis" and to prohibit use of the terms "sinusitis" and "associated with sinusitis" elsewhere on the labeling. This proposal is part of FDA's ongoing review of OTC drug products. | 2004-08-02 | 2004 | 8 | https://www.federalregister.gov/documents/2004/08/02/04-17445/cold-cough-allergy-bronchodilator-and-antiasthmatic-drug-products-for-over-the-counter-human-use | https://www.govinfo.gov/content/pkg/FR-2004-08-02/pdf/04-17445.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-the-counter (OTC) nasal decongestant drug products (drug products used to relieve nasal congestion due to a cold, hay fever, or other upper respiratory allergies)... |