FDA
Labetalol Hydrochloride
The FDA lists this product in 60 strengths and forms.
Composition
- Active ingredients
- LABETALOL HYDROCHLORIDE 10MG/2ML (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 · InjectableANDA075431-001 · Prescription
- LABETALOL HYDROCHLORIDE 300MG · TabletANDA212719-003 · Discontinued
- LABETALOL HYDROCHLORIDE 100MG · TabletANDA212719-001 · Discontinued
- LABETALOL HYDROCHLORIDE 200MG · Tablet
At a glance
- Brand name
- Labetalol Hydrochloride
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- Hikma
- Status
- Discontinued
- FDA approval
- 9 Nov 2020
- Application
- NDA213330-005