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FDA ANDA · ANDA075133

LABETALOL HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA075133
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-03
LATEST ACTION
2007-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2007-05-07Labeling · Supplement 11AP
2002-11-06Manufacturing (CMC) · Supplement 7AP
2002-06-06Manufacturing (CMC) · Supplement 5AP
2002-06-06Manufacturing (CMC) · Supplement 6AP
2002-02-20Manufacturing (CMC) · Supplement 4AP
2001-09-19Manufacturing (CMC) · Supplement 3AP
2001-08-31Manufacturing (CMC) · Supplement 2AP
1999-07-07Labeling · Supplement 1AP
1998-08-03Original — Review ↗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.

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