APPLICATION
ANDA075113
TYPE
ANDA
ORIGINAL APPROVAL
1998-08-04
LATEST ACTION
2015-11-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 200MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 300MG · TABLET · ORAL
LABETALOL HYDROCHLORIDEPrescription
LABETALOL HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2015-11-25Labeling · Supplement 28 · standardAP
2010-09-28Labeling · Supplement 16AP
2002-12-20Manufacturing (CMC) · Supplement 5AP
2002-12-20Manufacturing (CMC) · Supplement 6AP
2001-11-29Manufacturing (CMC) · Supplement 3AP
2001-11-29Manufacturing (CMC) · Supplement 4AP
2000-02-02Manufacturing (CMC) · Supplement 2AP
1999-04-30Labeling · Supplement 1AP
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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