APPLICATION
ANDA075215
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-29
LATEST ACTION
2015-02-23
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
2015-02-23Manufacturing (CMC) · Supplement 18AP
2002-12-24Manufacturing (CMC) · Supplement 8AP
2002-09-16Manufacturing (CMC) · Supplement 7AP
2002-01-17Manufacturing (CMC) · Supplement 6AP
2001-11-21Manufacturing (CMC) · Supplement 5AP
2000-10-02Manufacturing (CMC) · Supplement 3AP
2000-10-02Labeling · Supplement 4AP
2000-05-16Manufacturing (CMC) · Supplement 1AP
2000-05-16Manufacturing (CMC) · Supplement 2AP
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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