General MedicationsORALGeneric

EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE

EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE

Standard Dose

200MG;25MG;25MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 214058 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE Form and strength TABLET;ORAL - 200MG;25MG;25MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2022-09-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 214058 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE Form and strength TABLET;ORAL - 200MG;25MG;25MG Sponsor CIPLA LIMITED Submission history Latest submission status date: 2022-09-27 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.