General MedicationsINTRAVENOUSGeneric

DACOGEN

DECITABINE

Standard Dose

50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview DACOGEN is listed in Drugs@FDA under application 021790 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DECITABINE Form and strength INJECTABLE;INTRAVENOUS - 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor OTSUKA Submission history Latest submission status date: 2020-06-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview DACOGEN is listed in Drugs@FDA under application 021790 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DECITABINE Form and strength INJECTABLE;INTRAVENOUS - 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor OTSUKA Submission history Latest submission status date: 2020-06-29 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.