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General MedicationsRECTALGeneric

DIASTAT

DIAZEPAM

Standard Dose
20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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Form and strength GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAUSCH Submission history Latest submission status date: 2023-07-10 00:00:00.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Form and strength GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BAUSCH Submission history Latest submission status date: 2023-07-10 00:00:00.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.