federal_register: E7-19340
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E7-19340 | Drug Products Containing Hydrocodone; Enforcement Action Dates | Notice | The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing hydrocodone bitartrate, or any other salt or ester of hydrocodone (hereinafter collectively "hydrocodone"), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved hydrocodone products have been implicated in reports of medication errors, including improper dosing and dispensing the wrong drug. Some of these products omit important labeling warnings and information or are inappropriately labeled for use in young children. Drug products containing hydrocodone are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a drug product containing hydrocodone must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). | 2007-10-01 | 2007 | 10 | https://www.federalregister.gov/documents/2007/10/01/E7-19340/drug-products-containing-hydrocodone-enforcement-action-dates | https://www.govinfo.gov/content/pkg/FR-2007-10-01/pdf/E7-19340.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing hydrocodone bitartrate, or any other salt or ester of hydrocodone (hereinafter... |