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General MedicationsTABLETGeneric

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

EMTRICITABINE, TENOFOVIR ALAFENAMIDE

Standard Dose
200MG/25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 211680 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMTRICITABINE, TENOFOVIR ALAFENAMIDE Form and strength TABLET - 200MG/25MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2025-10-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 211680 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMTRICITABINE, TENOFOVIR ALAFENAMIDE Form and strength TABLET - 200MG/25MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2025-10-10 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.