APPLICATION
NDA018538
TYPE
NDA
ORIGINAL APPROVAL
1983-07-06
LATEST ACTION
2021-03-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LOZOL · ReferenceDiscontinued
INDAPAMIDE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LOZOL · ReferenceDiscontinued
INDAPAMIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2000-10-10Labeling · Supplement 26 · standardAP
2000-03-07Manufacturing (CMC) · Supplement 27 · standardAP
1998-12-11Manufacturing (CMC) · Supplement 25 · standardAP
1998-01-27Manufacturing (CMC) · Supplement 24 · standardAP
1996-10-29Labeling · Supplement 21 · standardAP
1996-10-29Labeling · Supplement 20 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 22 · standardAP
1996-02-26Manufacturing (CMC) · Supplement 23 · standardAP
1993-08-19Manufacturing (CMC) · Supplement 18 · standardAP
1993-04-29Efficacy · Supplement 17AP
1993-03-31Labeling · Supplement 19 · standardAP
1992-06-24Labeling · Supplement 16AP
1992-06-23Manufacturing (CMC) · Supplement 13 · standardAP
1992-04-01Manufacturing (CMC) · Supplement 15 · standardAP
1991-09-25Labeling · Supplement 14AP
1990-03-08Manufacturing (CMC) · Supplement 12 · standardAP
1990-01-03Manufacturing (CMC) · Supplement 9 · standardAP
1989-10-13Manufacturing (CMC) · Supplement 11 · standardAP
1989-07-10Manufacturing (CMC) · Supplement 10 · standardAP
1989-02-23Manufacturing (CMC) · Supplement 8 · standardAP
1988-11-29Manufacturing (CMC) · Supplement 7 · standardAP
1988-11-09Labeling · Supplement 6AP
1988-07-08Manufacturing (CMC) · Supplement 5 · standardAP
1987-06-30Manufacturing (CMC) · Supplement 4 · standardAP
1984-04-10Manufacturing (CMC) · Supplement 3 · standardAP
1983-11-29Manufacturing (CMC) · Supplement 1 · standardAP
1983-10-12Manufacturing (CMC) · Supplement 2 · standardAP
1983-07-06Type 1 - New Molecular Entity · 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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