ActiveRegulation
Determination That TAXOTERE (Docetaxel) Injection, 40 Milligrams/Milliliter Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Health and Human Services Department, Food and Drug Administration
NAICS 325412
Source: Federal Register
OverviewIntelligenceProposals
Key Details
- Posted Date
- NAICS Code
- 325412
- Source
- Federal Register
- Contract Type
- regulation
Description
The Food and Drug Administration (FDA) has determined that TAXOTERE (docetaxel) Injection, 40 milligrams/milliliter (mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for docetaxel injection, 40 mg/mL, if all other legal and regulatory requirements are met.
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Data sourced from Federal Register