APPLICATION
NDA019425
TYPE
NDA
ORIGINAL APPROVAL
1985-12-31
LATEST ACTION
2010-11-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TRANDATE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-12-18Manufacturing (CMC) · Supplement 20 · standardAP
1998-08-13Labeling · Supplement 19 · standardAP
1997-05-01Manufacturing (CMC) · Supplement 17 · standardAP
1994-04-20Labeling · Supplement 16 · standardAP
1993-05-27Labeling · Supplement 15 · standardAP
1991-06-05Labeling · Supplement 13AP
1991-02-01Labeling · Supplement 12AP
1990-11-07Labeling · Supplement 9AP
1990-06-07Labeling · Supplement 11AP
1990-03-23Manufacturing (CMC) · Supplement 8 · standardAP
1989-10-19Labeling · Supplement 6AP
1989-10-19Labeling · Supplement 7AP
1987-11-16Manufacturing (CMC) · Supplement 5 · standardAP
1987-11-13Manufacturing (CMC) · Supplement 4 · standardAP
1987-09-22Labeling · Supplement 3AP
1987-05-22Manufacturing (CMC) · Supplement 2 · standardAP
1986-11-13Labeling · Supplement 1AP
1985-12-31Type 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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