APPLICATION
NDA010251
TYPE
NDA
ORIGINAL APPROVAL
1956-03-01
LATEST ACTION
2002-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
INVERSINE · ReferenceDiscontinued
MECAMYLAMINE HYDROCHLORIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-01-24Manufacturing (CMC) · Supplement 23 · priorityAP
2001-03-20Manufacturing (CMC) · Supplement 22 · priorityAP
2000-03-31Manufacturing (CMC) · Supplement 21 · priorityAP
2000-03-31Labeling · Supplement 20 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 19 · priorityAP
1994-12-08Labeling · Supplement 18 · standardAP
1994-09-26Manufacturing (CMC) · Supplement 17 · priorityAP
1988-09-06Manufacturing (CMC) · Supplement 16 · priorityAP
1988-06-22Manufacturing (CMC) · Supplement 15 · priorityAP
1985-11-04Labeling · Supplement 14AP
1985-09-06Labeling · Supplement 13AP
1980-11-14Labeling · Supplement 12AP
1980-04-30Manufacturing (CMC) · Supplement 11 · priorityAP
1979-09-27Labeling · Supplement 10AP
1976-09-01Labeling · Supplement 9AP
1956-03-01Type 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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