APPLICATION
NDA012524
TYPE
NDA
ORIGINAL APPROVAL
1960-10-21
LATEST ACTION
1998-04-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ENDURON · ReferenceDiscontinued
METHYCLOTHIAZIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ENDURON · ReferenceDiscontinued
METHYCLOTHIAZIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1998-04-16Manufacturing (CMC) · Supplement 34 · standardAP
1988-07-26Labeling · Supplement 29 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 32 · standardAP
1984-01-25Manufacturing (CMC) · Supplement 31 · standardAP
1982-06-23Labeling · Supplement 30 · standardAP
1981-06-15Labeling · Supplement 27 · standardAP
1981-06-15Labeling · Supplement 26 · standardAP
1960-10-21Type 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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