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FDA ANDA · ANDA217949

LABETALOL HYDROCHLORIDE

Sponsor: MACLEODS PHARMS LTD

APPLICATION
ANDA217949
TYPE
ANDA
ORIGINAL APPROVAL
2025-09-23
LATEST ACTION
2025-09-23
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

2025-09-23UNKNOWN · Original · standardAP
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Related on SPEQ

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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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