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General MedicationsORALGeneric

DALMANE

FLURAZEPAM HYDROCHLORIDE

Standard Dose
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: PRIORITY Marketing status: Discontinued
Summary

Approval overview DALMANE is listed in Drugs@FDA under application 016721 (NDA).

Review priority: PRIORITY Marketing status: Discontinued Active ingredient FLURAZEPAM HYDROCHLORIDE Form and strength CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor VALEANT PHARM INTL Submission history Latest submission status date: 2009-03-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview DALMANE is listed in Drugs@FDA under application 016721 (NDA). Review priority: PRIORITY Marketing status: Discontinued Active ingredient FLURAZEPAM HYDROCHLORIDE Form and strength CAPSULE;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor VALEANT PHARM INTL Submission history Latest submission status date: 2009-03-27 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: PRIORITY

Interaction Notes

  • No interaction notes stored yet.