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General MedicationsTABLETGeneric

BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE

Standard Dose
120MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 218766 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Form and strength TABLET - 120MG Sponsor CIPLA LTD Submission history Latest submission status date: 2025-10-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 218766 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE Form and strength TABLET - 120MG Sponsor CIPLA LTD Submission history Latest submission status date: 2025-10-14 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.