APPLICATION
NDA018687
TYPE
NDA
ORIGINAL APPROVAL
1984-08-01
LATEST ACTION
2000-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NORMODYNE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NORMODYNE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NORMODYNE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
NORMODYNE · ReferenceDiscontinued
LABETALOL HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-12-22Manufacturing (CMC) · Supplement 23 · standardAP
2000-10-27Manufacturing (CMC) · Supplement 22 · standardAP
2000-04-25Labeling · Supplement 21 · standardAP
2000-01-27Manufacturing (CMC) · Supplement 20 · standardAP
1993-05-28Manufacturing (CMC) · Supplement 19 · standardAP
1993-01-27Manufacturing (CMC) · Supplement 18 · standardAP
1992-10-15Labeling · Supplement 16 · standardAP
1991-09-16Manufacturing (CMC) · Supplement 17 · standardAP
1990-11-07Labeling · Supplement 15 · standardAP
1989-06-16Labeling · Supplement 14 · standardAP
1989-06-16Labeling · Supplement 12 · standardAP
1989-02-23Manufacturing (CMC) · Supplement 11 · standardAP
1988-11-22Manufacturing (CMC) · Supplement 13 · standardAP
1988-04-14Labeling · Supplement 10 · standardAP
1987-08-31Labeling · Supplement 5 · standardAP
1987-08-31Labeling · Supplement 8 · standardAP
1987-08-31Labeling · Supplement 2 · standardAP
1987-02-05Manufacturing (CMC) · Supplement 9 · standardAP
1986-08-08Manufacturing (CMC) · Supplement 7 · standardAP
1986-01-14Manufacturing (CMC) · Supplement 6 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 3 · standardAP
1984-08-01Type 3 - New Dosage Form · 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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