General MedicationsRECTALGeneric

DIASTAT

DIAZEPAM

Standard Dose

5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N/A Marketing status: Discontinued

Summary

Approval overview DIASTAT is listed in Drugs@FDA under application 020648 (NDA).

Review priority: N/A Marketing status: Discontinued Active ingredient DIAZEPAM Form and strength GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAUSCH Submission history Latest submission status date: 2023-07-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview DIASTAT is listed in Drugs@FDA under application 020648 (NDA). Review priority: N/A Marketing status: Discontinued Active ingredient DIAZEPAM Form and strength GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAUSCH Submission history Latest submission status date: 2023-07-10 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: N/A

Interaction Notes

No interaction notes stored yet.