← FDA DRUG APPROVALS

FDA ANDA · ANDA209603

LABETALOL HYDROCHLORIDE

Sponsor: APPCO

APPLICATION
ANDA209603
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-20
LATEST ACTION
2024-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 400MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 200MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 300MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 100MG · TABLET · ORAL

Approval history

2024-10-18Manufacturing (CMC) · Supplement 6 · unknownAP
2018-06-20UNKNOWN · Original · standardAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →