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General MedicationsORALGeneric

ZOLPIMIST

ZOLPIDEM TARTRATE

Standard Dose
5MG/SPRAY
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview ZOLPIMIST is listed in Drugs@FDA under application 022196 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient ZOLPIDEM TARTRATE Form and strength SPRAY, METERED;ORAL - 5MG/SPRAY Sponsor AYTU Submission history Latest submission status date: 2019-08-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview ZOLPIMIST is listed in Drugs@FDA under application 022196 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient ZOLPIDEM TARTRATE Form and strength SPRAY, METERED;ORAL - 5MG/SPRAY Sponsor AYTU Submission history Latest submission status date: 2019-08-18 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.