General MedicationsORALGeneric

DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE

Standard Dose

50MG/200MG/25MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 215448 (NDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE Form and strength TABLET; ORAL - 50MG/200MG/25MG Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2023-05-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE is listed in Drugs@FDA under application 215448 (NDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE Form and strength TABLET; ORAL - 50MG/200MG/25MG Sponsor AUROBINDO PHARMA USA Submission history Latest submission status date: 2023-05-26 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.