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General MedicationsINTRAVENOUSStandard

GEMCITABINE HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE

Standard Dose
1GM/10ML (100MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GEMCITABINE HYDROCHLORIDE is listed in Drugs@FDA under application 209604 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 1GM/10ML (100MG/ML) Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2024-09-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview GEMCITABINE HYDROCHLORIDE is listed in Drugs@FDA under application 209604 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 1GM/10ML (100MG/ML) Sponsor ACCORD HLTHCARE Submission history Latest submission status date: 2024-09-24 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.