APPLICATION
NDA018686
TYPE
NDA
ORIGINAL APPROVAL
1984-08-01
LATEST ACTION
2001-11-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
NORMODYNE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2001-11-06Manufacturing (CMC) · Supplement 29 · priorityAP
2001-06-05Manufacturing (CMC) · Supplement 28 · priorityAP
2000-11-16Manufacturing (CMC) · Supplement 27 · priorityAP
2000-04-25Labeling · Supplement 26 · priorityAP
1999-08-10Manufacturing (CMC) · Supplement 25 · priorityAP
1999-04-29Manufacturing (CMC) · Supplement 24 · priorityAP
1997-11-14Manufacturing (CMC) · Supplement 23 · priorityAP
1997-07-09Manufacturing (CMC) · Supplement 22 · priorityAP
1996-11-25Labeling · Supplement 21 · priorityAP
1996-11-07Manufacturing (CMC) · Supplement 20 · priorityAP
1995-01-12Labeling · Supplement 19 · priorityAP
1993-05-28Manufacturing (CMC) · Supplement 18 · priorityAP
1992-10-15Labeling · Supplement 16 · priorityAP
1991-09-16Manufacturing (CMC) · Supplement 17 · priorityAP
1990-11-07Labeling · Supplement 15 · priorityAP
1989-10-19Labeling · Supplement 13 · priorityAP
1989-10-19Labeling · Supplement 10 · priorityAP
1989-07-21Manufacturing (CMC) · Supplement 12 · priorityAP
1988-11-22Manufacturing (CMC) · Supplement 11 · priorityAP
1988-04-14Labeling · Supplement 9 · priorityAP
1987-08-31Labeling · Supplement 5 · priorityAP
1987-08-31Labeling · Supplement 6 · priorityAP
1987-06-12Manufacturing (CMC) · Supplement 8 · priorityAP
1987-02-05Manufacturing (CMC) · Supplement 7 · priorityAP
1986-08-29Manufacturing (CMC) · Supplement 4 · priorityAP
1986-08-08Manufacturing (CMC) · Supplement 3 · priorityAP
1986-04-04Manufacturing (CMC) · Supplement 1 · priorityAP
1986-01-14Manufacturing (CMC) · Supplement 2 · priorityAP
1984-08-01Type 1 - New Molecular Entity · Original · priorityAP
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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