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Medicines · US (FDA)

FDA 1999

FDA

Labetalol Hydrochloride

Approved 29 Nov 1999InjectionInjectable

The FDA lists this product in 60 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: LABETALOL HYDROCHLORIDE 5MG/ML

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

LABETALOL HYDROCHLORIDE 300MG · TabletANDA075133-003 · Prescription
LABETALOL HYDROCHLORIDE 100MG · TabletANDA075133-001 · Prescription
LABETALOL HYDROCHLORIDE 200MG · TabletANDA075133-002 · Prescription
LABETALOL HYDROCHLORIDE 100MG · TabletANDA074787-001 · Prescription
LABETALOL HYDROCHLORIDE 400MG · TabletANDA074787-004 · Prescription
LABETALOL HYDROCHLORIDE 200MG · TabletANDA074787-002 · Prescription
LABETALOL HYDROCHLORIDE 300MG · TabletANDA074787-003 · Prescription
LABETALOL HYDROCHLORIDE 5MG/ML · InjectableThis page
LABETALOL HYDROCHLORIDE 300MG · TabletANDA212719-003 · Discontinued
LABETALOL HYDROCHLORIDE 100MG · Tablet

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA212719-001 · Discontinued

LABETALOL HYDROCHLORIDE 200MG · TabletANDA212719-002 · Discontinued

LABETALOL HYDROCHLORIDE 200MG · TabletANDA212990-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA212990-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA212990-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA075223-002 · Discontinued

LABETALOL HYDROCHLORIDE 300MG · TabletANDA075223-003 · Discontinued

LABETALOL HYDROCHLORIDE 100MG · TabletANDA075223-001 · Discontinued

LABETALOL HYDROCHLORIDE 200MG · TabletANDA207743-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA207743-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA207743-001 · Prescription

LABETALOL HYDROCHLORIDE 10MG/2ML (5MG/ML) · SolutionNDA213330-005 · Discontinued

LABETALOL HYDROCHLORIDE 20MG/4ML (5MG/ML) · SolutionNDA213330-006 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA218870-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075239-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA076051-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA079134-001 · Discontinued

LABETALOL HYDROCHLORIDE 300MG · TabletANDA211953-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA211953-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA211953-002 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA090699-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA075215-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA075215-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA075215-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075240-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075355-001 · Discontinued

LABETALOL HYDROCHLORIDE 300MG · TabletANDA200908-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA200908-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA200908-002 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA074989-002 · Discontinued

LABETALOL HYDROCHLORIDE 300MG · TabletANDA074989-003 · Discontinued

LABETALOL HYDROCHLORIDE 100MG · TabletANDA074989-001 · Discontinued

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075242-001 · Discontinued

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075303-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA075524-001 · Discontinued

LABETALOL HYDROCHLORIDE 200MG · TabletANDA211325-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA211325-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA211325-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA075113-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA075113-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA075113-001 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA207863-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA207863-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA207863-002 · Prescription

LABETALOL HYDROCHLORIDE 400MG · TabletANDA209603-004 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA209603-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA209603-003 · Prescription

LABETALOL HYDROCHLORIDE 100MG · TabletANDA209603-001 · Prescription

LABETALOL HYDROCHLORIDE 5MG/ML · InjectableANDA214533-001 · Prescription

LABETALOL HYDROCHLORIDE 200MG · TabletANDA217949-002 · Prescription

LABETALOL HYDROCHLORIDE 300MG · TabletANDA217949-003 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA075431.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Labetalol Hydrochloride
Route: Injection
Dosage form: Injectable
Applicant: Rising
Status: Prescription
FDA approval: 29 Nov 1999
Application: ANDA075431-001