federal_register: 2011-29484

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-29484 Determination That TRAVATAN (Travoprost Ophthalmic Solution), 0.004%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness Notice The Food and Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for travoprost ophthalmic solution, 0.004%, if all other legal and regulatory requirements are met. 2011-11-16 2011 11 https://www.federalregister.gov/documents/2011/11/16/2011-29484/determination-that-travatan-travoprost-ophthalmic-solution-0004-was-not-withdrawn-from-sale-for https://www.govinfo.gov/content/pkg/FR-2011-11-16/pdf/2011-29484.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has determined that TRAVATAN (travoprost ophthalmic solution), 0.004%, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug...

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