← FDA DRUG APPROVALS

FDA NDA · NDA218038

DILTIAZEM HYDROCHLORIDE IN SODIUM CHLORIDE

diltiazem hydrochloride

Sponsor: HQ SPCLT PHARMA

APPLICATION
NDA218038
TYPE
NDA
ORIGINAL APPROVAL
2025-02-21
LATEST ACTION
2025-02-21
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 250MG/250ML (1MG/ML) · SOLUTION · INTRAVENOUS
DILTIAZEM HYDROCHLORIDE IN 0.72% SODIUM CHLORIDE · ReferencePrescription
DILTIAZEM HYDROCHLORIDE 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-02-21Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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