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General MedicationsINTRAVENOUSStandard

PREVDUO

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

Standard Dose
0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview PREVDUO is listed in Drugs@FDA under application 216903 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE Form and strength SOLUTION;INTRAVENOUS - 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) Sponsor AZURITY Submission history Latest submission status date: 2023-02-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview PREVDUO is listed in Drugs@FDA under application 216903 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE Form and strength SOLUTION;INTRAVENOUS - 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) Sponsor AZURITY Submission history Latest submission status date: 2023-02-23 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.