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General MedicationsORALStandard

DILTIAZEM HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE

Standard Dose
420MG
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 206641 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 420MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2025-06-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview DILTIAZEM HYDROCHLORIDE is listed in Drugs@FDA under application 206641 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength CAPSULE, EXTENDED RELEASE;ORAL - 420MG Sponsor ZYDUS PHARMS Submission history Latest submission status date: 2025-06-26 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.