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General MedicationsINTRAMUSCULAR, INTRAVENOUSStandard

GLYRX-PF

GLYCOPYRROLATE

Standard Dose
1MG/5ML (0.2MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview GLYRX-PF is listed in Drugs@FDA under application 210997 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1MG/5ML (0.2MG/ML) Sponsor EXELA PHARMA Submission history Latest submission status date: 2025-07-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview GLYRX-PF is listed in Drugs@FDA under application 210997 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 1MG/5ML (0.2MG/ML) Sponsor EXELA PHARMA Submission history Latest submission status date: 2025-07-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.