federal_register: 2010-30622

All Federal Register documents (rules, proposed rules, notices, presidential documents) from 1994 to present. Nearly 1M documents with full-text search.

This data as json

document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2010-30622 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Potassium) Chewable Tablet and Six Other AUGMENTIN (Amoxicillin; Clavulanate Potassium) Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that the AUGMENTIN (amoxicillin; clavulanate potassium) drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness.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. 2010-12-07 2010 12 https://www.federalregister.gov/documents/2010/12/07/2010-30622/determination-that-augmentin-125-amoxicillin-clavulanate-potassium-chewable-tablet-and-six-other https://www.govinfo.gov/content/pkg/FR-2010-12-07/pdf/2010-30622.pdf Health and Human Services Department; Food and Drug Administration 221,199 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has determined that the AUGMENTIN (amoxicillin; clavulanate potassium) drug products listed in this notice were not withdrawn from sale for reasons of safety or effectiveness.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...

Links from other tables