General MedicationsORALStandard

DICYCLOMINE HYDROCHLORIDE

Standard Dose

40MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: UNKNOWN Marketing status: Prescription

Summary

Approval overview DICYCLOMINE HYDROCHLORIDE is listed in Drugs@FDA under application 216736 (ANDA).

Review priority: UNKNOWN Marketing status: Prescription Active ingredient DICYCLOMINE HYDROCHLORIDE Form and strength TABLET;ORAL - 40MG Sponsor RUBICON RESEARCH Submission history Latest submission status date: 2025-09-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview DICYCLOMINE HYDROCHLORIDE is listed in Drugs@FDA under application 216736 (ANDA). Review priority: UNKNOWN Marketing status: Prescription Active ingredient DICYCLOMINE HYDROCHLORIDE Form and strength TABLET;ORAL - 40MG Sponsor RUBICON RESEARCH Submission history Latest submission status date: 2025-09-15 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: UNKNOWN

Interaction Notes

No interaction notes stored yet.