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General MedicationsINJECTIONGeneric

ROMAZICON

FLUMAZENIL

Standard Dose
0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 ROMAZICON is listed in Drugs@FDA under application 020073 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUMAZENIL Form and strength INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HOFFMANN LA ROCHE Submission history Latest submission status date: 2007-10-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview ROMAZICON is listed in Drugs@FDA under application 020073 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FLUMAZENIL Form and strength INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor HOFFMANN LA ROCHE Submission history Latest submission status date: 2007-10-04 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.