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FDA NDA · NDA215252

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5%

Sponsor: EXELA PHARMA

APPLICATION
NDA215252
TYPE
NDA
ORIGINAL APPROVAL
2021-10-28
LATEST ACTION
2021-10-28
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 125MG/125ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
DILTIAZEM HYDROCHLORIDE IN DEXTROSE 5% · ReferenceDiscontinued
DILTIAZEM HYDROCHLORIDE 250MG/250ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS

Approval history

2021-10-28Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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