General MedicationsORALStandard
GLYCOPYRROLATE
GLYCOPYRROLATE
Standard Dose
1MG/5ML
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 220062 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;ORAL - 1MG/5ML Sponsor BIONPHARMA Submission history Latest submission status date: 2025-12-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview GLYCOPYRROLATE is listed in Drugs@FDA under application 220062 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient GLYCOPYRROLATE Form and strength SOLUTION;ORAL - 1MG/5ML Sponsor BIONPHARMA Submission history Latest submission status date: 2025-12-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.