APPLICATION
ANDA207863
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-04
LATEST ACTION
2026-03-11
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
2026-03-11Labeling · Supplement 4 · standardAP
2019-02-04UNKNOWN · Original · standardAP
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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