General MedicationsIV (INFUSION)Generic

BENDAMUSTINE HYDROCHLORIDE

Standard Dose

100MG/VIAL

Max Dose

Refer to approved labeling

Primary Use

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

Summary

Approval overview BENDAMUSTINE HYDROCHLORIDE is listed in Drugs@FDA under application 209814 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BENDAMUSTINE HYDROCHLORIDE Form and strength POWDER;IV (INFUSION) - 100MG/VIAL Sponsor CELERITY PHARMS Submission history Latest submission status date: 2019-01-25 00:00:00.

Structured Monograph

Clinical summary

Approval overview BENDAMUSTINE HYDROCHLORIDE is listed in Drugs@FDA under application 209814 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BENDAMUSTINE HYDROCHLORIDE Form and strength POWDER;IV (INFUSION) - 100MG/VIAL Sponsor CELERITY PHARMS Submission history Latest submission status date: 2019-01-25 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

No interaction notes stored yet.