General MedicationsINTRAVENOUSGeneric

ROMIDEPSIN

Standard Dose

10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ROMIDEPSIN is listed in Drugs@FDA under application 208574 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient ROMIDEPSIN Form and strength SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TEVA PHARMS USA INC Submission history Latest submission status date: 2021-12-08 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROMIDEPSIN is listed in Drugs@FDA under application 208574 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient ROMIDEPSIN Form and strength SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor TEVA PHARMS USA INC Submission history Latest submission status date: 2021-12-08 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.