The U.S. Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) numbered 079188 for EMTRICITABINE, a nucleoside reverse transcriptase inhibitor used in HIV treatment.
The approved product is manufactured by Aurobindo Pharma Limited and is marketed as an oral capsule containing 200 mg of EMTRICITABINE. It is listed under the National Drug Code (NDC) identifiers 65862-301-30 and 65862-301-05 and is classified as a human prescription drug.
Submission records show original FDA correspondence dated December 19, 2008 and May 11, 2018. The latest submission status was recorded as approved (AP) on March 15, 2023.
This approval provides a generic option for EMTRICITABINE, potentially expanding patient access to HIV therapy.
Actualités réglementaires15 sept. 2026•3 min de lecture
FDA Approves Aurobindo Pharma’s Generic EMTRICITABINE (ANDA 079188)
The FDA has approved Aurobindo Pharma’s oral 200 mg EMTRICITABINE capsule under ANDA 079188, confirming its prescription status.
Compilé par l'équipe Pharmacountry · Source : FDA.gov
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