General MedicationsINTRAMUSCULAR, INTRAVENOUSStandard
GLYCOPYRROLATE
GLYCOPYRROLATE
Standard Dose
0.6MG/3ML (0.2MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview GLYCOPYRROLATE is listed in Drugs@FDA under application 214919 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 0.6MG/3ML (0.2MG/ML) Sponsor FRESENIUS KABI USA Submission history Latest submission status date: 2025-07-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview GLYCOPYRROLATE is listed in Drugs@FDA under application 214919 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;INTRAMUSCULAR, INTRAVENOUS - 0.6MG/3ML (0.2MG/ML) Sponsor FRESENIUS KABI USA 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.