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General MedicationsINJECTIONStandard

GEMCITABINE HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE

Standard Dose
1GM/26.3ML (38MG/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 213175 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 1GM/26.3ML (38MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2023-03-07 00:00:00.

Structured Monograph

Clinical summary

Approval overview GEMCITABINE HYDROCHLORIDE is listed in Drugs@FDA under application 213175 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - 1GM/26.3ML (38MG/ML) Sponsor HIKMA Submission history Latest submission status date: 2023-03-07 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.