General MedicationsORALStandard

DILTIAZEM HYDROCHLORIDE

Standard Dose

60MG

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview DILTIAZEM HYDROCHLORIDE is listed in Drugs@FDA under application 219073 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 60MG Sponsor UTOPIC PHARMS Submission history Latest submission status date: 2025-03-24 00:00:00.

Structured Monograph

Clinical summary

Approval overview DILTIAZEM HYDROCHLORIDE is listed in Drugs@FDA under application 219073 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 60MG Sponsor UTOPIC PHARMS Submission history Latest submission status date: 2025-03-24 00:00:00. Submission type: ORIG.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.