ActiveRegulation
Determination That AUGMENTIN `125' (Amoxicillin; Clavulanate Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin; Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Health and Human Services Department, Food and Drug Administration
NAICS 325412
Source: Federal Register
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Key Details
- Posted Date
- NAICS Code
- 325412
- Source
- Federal Register
- Contract Type
- regulation
Description
The Food and Drug Administration (FDA) has determined that the AUGMENTIN (amoxicillin; clavulanate potassium) drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
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Data sourced from Federal Register