General MedicationsINJECTIONStandard

GEMCITABINE HYDROCHLORIDE

Standard Dose

EQ 2GM BASE/VIAL

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 202997 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 2GM BASE/VIAL Sponsor DR REDDYS LABS LTD 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 202997 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GEMCITABINE HYDROCHLORIDE Form and strength INJECTABLE;INJECTION - EQ 2GM BASE/VIAL Sponsor DR REDDYS LABS LTD 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.