General MedicationsORALGeneric

TRIFLURIDINE; TIPIRACIL

Standard Dose

15MG/6.14MG

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview TRIFLURIDINE; TIPIRACIL is listed in Drugs@FDA under application 214036 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TRIFLURIDINE; TIPIRACIL Form and strength TABLET;ORAL - 15MG/6.14MG Sponsor INTAS PHARMS LTD Submission history Latest submission status date: 2022-10-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview TRIFLURIDINE; TIPIRACIL is listed in Drugs@FDA under application 214036 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient TRIFLURIDINE; TIPIRACIL Form and strength TABLET;ORAL - 15MG/6.14MG Sponsor INTAS PHARMS LTD Submission history Latest submission status date: 2022-10-13 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.