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General MedicationsINTRAVENOUSGeneric

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

DILTIAZEM HYDROCHLORIDE

Standard Dose
125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is listed in Drugs@FDA under application 215252 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor EXELA PHARMA Submission history Latest submission status date: 2021-10-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% is listed in Drugs@FDA under application 215252 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient DILTIAZEM HYDROCHLORIDE Form and strength SOLUTION;INTRAVENOUS - 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor EXELA PHARMA Submission history Latest submission status date: 2021-10-28 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.