federal_register: 00-15556
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 00-15556 | Determination That Fluoxetine Hydrochloride 20-Milligram Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | Notice | The Food and Drug Administration (FDA) is announcing its determination that fluoxetine hydrochloride 20-milligram (mg) tablets (Prozac<Register>) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA's) for fluoxetine hydrochloride 20-mg tablets. | 2000-06-21 | 2000 | 6 | https://www.federalregister.gov/documents/2000/06/21/00-15556/determination-that-fluoxetine-hydrochloride-20-milligram-tablets-were-not-withdrawn-from-sale-for | https://www.govinfo.gov/content/pkg/FR-2000-06-21/pdf/00-15556.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing its determination that fluoxetine hydrochloride 20-milligram (mg) tablets (Prozac<Register>) were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to... |