RecallHawk

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

EXELA PHARMA

Summary

FDA approved DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% by EXELA PHARMA. NDA (New Drug) approval (Type 5 - New Formulation or New Manufacturer) on 2021-10-28. SOLUTION, INTRAVENOUS.

Details

Source

Drug Approval

External ID

NDA215252-1

Action Date

2021-10-28

Status

Approved

Category

drug

Product Code

NDA (New Drug)

Product Description

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%, SOLUTION, INTRAVENOUS. Application: NDA215252

Context & Analysis

EXELA PHARMA has 5 FDA actions in our database.

Frequently Asked Questions

How often does EXELA PHARMA have FDA actions?

EXELA PHARMA has 5 FDA actions in our database, including 0 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "NDA215252-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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