APPLICATION
NDA018343
TYPE
NDA
ORIGINAL APPROVAL
1981-04-06
LATEST ACTION
2017-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CAPOTEN · ReferenceDiscontinued
CAPTOPRIL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-04-20Labeling · Supplement 73 · standardAP
1998-01-09Manufacturing (CMC) · Supplement 72 · priorityAP
1997-08-21Manufacturing (CMC) · Supplement 71 · priorityAP
1996-07-31Labeling · Supplement 68 · standardAP
1996-06-25Manufacturing (CMC) · Supplement 70 · priorityAP
1996-03-01Manufacturing (CMC) · Supplement 69 · priorityAP
1995-06-19Manufacturing (CMC) · Supplement 57 · priorityAP
1995-06-13Manufacturing (CMC) · Supplement 66 · priorityAP
1995-03-06Manufacturing (CMC) · Supplement 67 · priorityAP
1994-03-31Labeling · Supplement 63 · standardAP
1994-01-28Efficacy · Supplement 64 · priorityAP
1993-11-04Labeling · Supplement 65 · standardAP
1993-09-23Efficacy · Supplement 48AP
1993-05-12Manufacturing (CMC) · Supplement 62 · priorityAP
1992-12-21Manufacturing (CMC) · Supplement 59 · priorityAP
1992-09-03Labeling · Supplement 60AP
1992-06-25Labeling · Supplement 61AP
1992-05-07Manufacturing (CMC) · Supplement 56 · priorityAP
1992-01-14Manufacturing (CMC) · Supplement 58 · priorityAP
1991-10-07Manufacturing (CMC) · Supplement 55 · priorityAP
1991-04-12Manufacturing (CMC) · Supplement 53 · priorityAP
1991-03-21Labeling · Supplement 51AP
1991-01-31Manufacturing (CMC) · Supplement 54 · priorityAP
1990-11-05Manufacturing (CMC) · Supplement 52 · priorityAP
1990-09-27Labeling · Supplement 50AP
1990-05-10Manufacturing (CMC) · Supplement 49 · priorityAP
1990-03-23Manufacturing (CMC) · Supplement 32 · priorityAP
1989-10-19Labeling · Supplement 46AP
1989-05-03Labeling · Supplement 47AP
1988-05-13Efficacy · Supplement 40AP
1988-05-13Manufacturing (CMC) · Supplement 45 · priorityAP
1988-02-19Labeling · Supplement 44AP
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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