APPLICATION
NDA018709
TYPE
NDA
ORIGINAL APPROVAL
1984-10-12
LATEST ACTION
2009-02-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPOZIDE 50/25 · ReferenceDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOZIDE 25/15 · ReferenceDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOZIDE 50/15 · ReferenceDiscontinued
CAPTOPRIL 50MG, HYDROCHLOROTHIAZIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOZIDE 25/25 · ReferenceDiscontinued
CAPTOPRIL 25MG, HYDROCHLOROTHIAZIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1998-06-03Labeling · Supplement 30 · standardAP
1997-05-20Manufacturing (CMC) · Supplement 31 · standardAP
1996-07-31Labeling · Supplement 26 · standardAP
1996-07-31Labeling · Supplement 27 · standardAP
1996-06-26Manufacturing (CMC) · Supplement 29 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 28 · standardAP
1995-10-06Manufacturing (CMC) · Supplement 25 · standardAP
1994-07-25Labeling · Supplement 21 · standardAP
1993-05-12Manufacturing (CMC) · Supplement 24 · standardAP
1992-10-15Labeling · Supplement 23 · standardAP
1992-06-25Labeling · Supplement 22 · standardAP
1992-03-05Manufacturing (CMC) · Supplement 20 · standardAP
1991-12-10Manufacturing (CMC) · Supplement 19 · standardAP
1991-10-24Efficacy · Supplement 9 · standardAP
1991-03-21Labeling · Supplement 17 · standardAP
1990-09-27Labeling · Supplement 16 · standardAP
1990-09-05Manufacturing (CMC) · Supplement 18 · standardAP
1989-10-19Labeling · Supplement 14 · standardAP
1989-05-03Labeling · Supplement 15 · standardAP
1988-06-22Labeling · Supplement 12 · standardAP
1987-10-06Manufacturing (CMC) · Supplement 11 · standardAP
1987-01-06Manufacturing (CMC) · Supplement 10 · standardAP
1986-11-10Manufacturing (CMC) · Supplement 5 · standardAP
1986-01-17Labeling · Supplement 8 · standardAP
1985-08-02Labeling · Supplement 7 · standardAP
1985-08-01Manufacturing (CMC) · Supplement 3 · standardAP
1985-07-15Manufacturing (CMC) · Supplement 6 · standardAP
1985-07-03Manufacturing (CMC) · Supplement 4 · standardAP
1985-02-07Manufacturing (CMC) · Supplement 2 · standardAP
1984-11-20Manufacturing (CMC) · Supplement 1 · standardAP
1984-10-12Type 4 - New Combination · 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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