General MedicationsORALStandard

TALICIA

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN

Standard Dose

250MG;EQ 10MG BASE;12.5MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview TALICIA is listed in Drugs@FDA under application 213004 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN Form and strength CAPSULE, DELAYED RELEASE;ORAL - 250MG;EQ 10MG BASE;12.5MG Sponsor TALICIA HOLDINGS Submission history Latest submission status date: 2024-05-01 00:00:00.

Structured Monograph

Clinical summary

Approval overview TALICIA is listed in Drugs@FDA under application 213004 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN Form and strength CAPSULE, DELAYED RELEASE;ORAL - 250MG;EQ 10MG BASE;12.5MG Sponsor TALICIA HOLDINGS Submission history Latest submission status date: 2024-05-01 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.