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FDA NDA · NDA213330

LABETALOL HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
NDA213330
TYPE
NDA
ORIGINAL APPROVAL
2020-11-09
LATEST ACTION
2024-08-19
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Prescription

Products

LABETALOL HYDROCHLORIDE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 10MG/2ML (5MG/ML) · SOLUTION · INTRAVENOUS
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE · ReferencePrescription
LABETALOL HYDROCHLORIDE 200MG/200ML (1MG/ML) · SOLUTION · INTRAVENOUS
LABETALOL HYDROCHLORIDE IN DEXTROSE · ReferencePrescription
LABETALOL HYDROCHLORIDE 200MG/200ML (1MG/ML) · SOLUTION · INTRAVENOUS
LABETALOL HYDROCHLORIDE · ReferencePrescription
LABETALOL HYDROCHLORIDE 20MG/4ML (5MG/ML) · SOLUTION · INTRAVENOUS
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE · ReferencePrescription
LABETALOL HYDROCHLORIDE 300MG/300ML (1MG/ML) · SOLUTION · INTRAVENOUS
LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE · ReferencePrescription
LABETALOL HYDROCHLORIDE 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-08-19Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2023-06-15Labeling · Supplement 5 · standard — Label ↗AP
2022-03-18Manufacturing (CMC) · Supplement 3 · standard — Letter ↗AP
2020-11-09Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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