federal_register: 2025-23419

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2025-23419 Determination That DEXCHLORPHENIRAMINE MALEATE (Dexchlorpheniramine Maleate, Oral Syrup, 2 Milligrams/5 Milliliters) Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA, Agency, or we) has determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not withdrawn from sale for reasons of safety or effectiveness.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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. 2025-12-19 2025 12 https://www.federalregister.gov/documents/2025/12/19/2025-23419/determination-that-dexchlorpheniramine-maleate-dexchlorpheniramine-maleate-oral-syrup-2-milligrams5 https://www.govinfo.gov/content/pkg/FR-2025-12-19/pdf/2025-23419.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) has determined that DEXCHLORPHENIRAMINE MALEATE (dexchlorpheniramine maleate, oral syrup, 2 milligrams (mg)/5 milliliters (ml)), was not withdrawn from sale for reasons of safety or effectiveness....

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