APPLICATION
NDA018716
TYPE
NDA
ORIGINAL APPROVAL
1984-08-01
LATEST ACTION
2024-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRANDATE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRANDATE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRANDATE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRANDATE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2014-10-27Manufacturing (CMC) · Supplement 27 · standardAP
2008-02-01Labeling · Supplement 25 · standardAP
1998-08-13Labeling · Supplement 22 · standardAP
1997-04-21Manufacturing (CMC) · Supplement 21 · standardAP
1993-05-27Labeling · Supplement 18AP
1993-05-27Labeling · Supplement 20 · standardAP
1991-06-05Labeling · Supplement 19AP
1991-02-01Labeling · Supplement 17AP
1990-11-07Labeling · Supplement 15AP
1990-06-07Labeling · Supplement 16AP
1989-12-22Manufacturing (CMC) · Supplement 14 · standardAP
1989-06-16Labeling · Supplement 11AP
1989-06-16Labeling · Supplement 12AP
1989-04-07Manufacturing (CMC) · Supplement 13 · standardAP
1987-09-22Labeling · Supplement 9AP
1987-08-27Manufacturing (CMC) · Supplement 10 · standardAP
1986-11-13Labeling · Supplement 8AP
1985-08-08Manufacturing (CMC) · Supplement 4 · standardAP
1985-05-24Labeling · Supplement 6AP
1985-05-24Labeling · Supplement 5AP
1985-04-16Manufacturing (CMC) · Supplement 2 · standardAP
1985-03-26Manufacturing (CMC) · Supplement 1 · standardAP
1984-08-01Type 5 - New Formulation or New Manufacturer · 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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