← FDA DRUG APPROVALS

FDA ANDA · ANDA074787

LABETALOL HYDROCHLORIDE

Sponsor: HERITAGE PHARMA

APPLICATION
ANDA074787
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-03
LATEST ACTION
2026-03-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2026-03-26Manufacturing (CMC) · Supplement 59 · unknownAP
2011-02-03Labeling · Supplement 31AP
2008-11-25Labeling · Supplement 26AP
2002-08-05Manufacturing (CMC) · Supplement 9AP
2002-08-05Manufacturing (CMC) · Supplement 14AP
2002-08-05Manufacturing (CMC) · Supplement 12AP
2002-07-29Manufacturing (CMC) · Supplement 13AP
2002-03-26Manufacturing (CMC) · Supplement 11AP
2001-09-12Manufacturing (CMC) · Supplement 10AP
2000-12-18Labeling · Supplement 8AP
2000-12-18Manufacturing (CMC) · Supplement 6AP
2000-01-28Manufacturing (CMC) · Supplement 7AP
1999-10-25Manufacturing (CMC) · Supplement 4AP
1999-10-25Manufacturing (CMC) · Supplement 2AP
1999-10-25Manufacturing (CMC) · Supplement 5AP
1999-10-25Manufacturing (CMC) · Supplement 3AP
1999-04-30Labeling · Supplement 1AP
1998-08-03Original — Label ↗AP
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 →