APPLICATION
NDA018154
TYPE
NDA
ORIGINAL APPROVAL
1979-10-18
LATEST ACTION
2015-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LONITEN · ReferenceDiscontinued
MINOXIDIL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LONITEN · ReferenceDiscontinued
MINOXIDIL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-08-08Manufacturing (CMC) · Supplement 22 · priorityAP
1996-03-11Manufacturing (CMC) · Supplement 21 · priorityAP
1994-04-08Labeling · Supplement 20 · standardAP
1994-04-08Manufacturing (CMC) · Supplement 19 · priorityAP
1993-02-17Labeling · Supplement 18 · standardAP
1992-05-19Labeling · Supplement 17AP
1987-10-20Labeling · Supplement 16AP
1986-12-22Labeling · Supplement 15AP
1986-07-28Manufacturing (CMC) · Supplement 14 · priorityAP
1985-12-19Labeling · Supplement 12AP
1985-10-15Labeling · Supplement 9AP
1984-11-28Manufacturing (CMC) · Supplement 7 · priorityAP
1984-02-07Manufacturing (CMC) · Supplement 6 · priorityAP
1983-06-09Labeling · Supplement 5AP
1982-12-07Labeling · Supplement 3AP
1982-04-12Labeling · Supplement 1AP
1982-04-12Labeling · Supplement 2AP
1982-02-08Labeling · Supplement 4AP
1979-10-18Type 1 - New Molecular Entity · Original · priorityAP
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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