General MedicationsINJECTIONStandard

IRINOTECAN HYDROCHLORIDE

Standard Dose

100MG/5ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview IRINOTECAN HYDROCHLORIDE is listed in Drugs@FDA under application 200771 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient IRINOTECAN HYDROCHLORIDE Form and strength INJECTABLE; INJECTION - 100MG/5ML Sponsor EMCURE PHARMS LTD Submission history Latest submission status date: 2020-08-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview IRINOTECAN HYDROCHLORIDE is listed in Drugs@FDA under application 200771 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient IRINOTECAN HYDROCHLORIDE Form and strength INJECTABLE; INJECTION - 100MG/5ML Sponsor EMCURE PHARMS LTD Submission history Latest submission status date: 2020-08-24 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.