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General MedicationsIV (INFUSION)Generic

BENDAMUSTINE HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE

Standard Dose
100MG/4ML (25MG/ML)
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 210410 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BENDAMUSTINE HYDROCHLORIDE Form and strength SOLUTION;IV (INFUSION) - 100MG/4ML (25MG/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2018-11-13 00:00:00.

Structured Monograph

Clinical summary

Approval overview BENDAMUSTINE HYDROCHLORIDE is listed in Drugs@FDA under application 210410 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient BENDAMUSTINE HYDROCHLORIDE Form and strength SOLUTION;IV (INFUSION) - 100MG/4ML (25MG/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2018-11-13 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.