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General MedicationsINTRAVENOUSGeneric

BIVALIRUDIN IN 0.9% SODIUM CHLORIDE

BIVALIRUDIN

Standard Dose
500MG/100ML (5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is listed in Drugs@FDA under application 208374 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient BIVALIRUDIN Form and strength SOLUTION;INTRAVENOUS - 500MG/100ML (5MG/ML) Sponsor BAXTER HLTHCARE CORP Submission history Latest submission status date: 2021-01-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is listed in Drugs@FDA under application 208374 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BIVALIRUDIN Form and strength SOLUTION;INTRAVENOUS - 500MG/100ML (5MG/ML) Sponsor BAXTER HLTHCARE CORP Submission history Latest submission status date: 2021-01-08 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.