federal_register: 2015-30051
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-30051 | Determination That TYLENOL WITH CODEINE (Acetaminophen With Codeine Phosphate) Oral Tablets, 325 Milligrams/7.5 Milligrams, 325 Milligrams/15 Milligrams, 325 Milligrams/30 Milligrams, and 325 Milligrams/60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA or Agency) has determined that TYLENOL WITH CODEINE (acetaminophen with codeine phosphate) oral tablets, 325 milligrams (mg)/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for TYLENOL WITH CODEINE (acetaminophen with codeine phosphate) oral tablets, 325 mg/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, if all other legal and regulatory requirements are met. | 2015-11-25 | 2015 | 11 | https://www.federalregister.gov/documents/2015/11/25/2015-30051/determination-that-tylenol-with-codeine-acetaminophen-with-codeine-phosphate-oral-tablets-325 | https://www.govinfo.gov/content/pkg/FR-2015-11-25/pdf/2015-30051.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) has determined that TYLENOL WITH CODEINE (acetaminophen with codeine phosphate) oral tablets, 325 milligrams (mg)/7.5 mg, 325 mg/15 mg, 325 mg/30 mg, and 325 mg/60 mg, were not withdrawn from sale for... |