APPLICATION
NDA018084
TYPE
NDA
ORIGINAL APPROVAL
1979-10-30
LATEST ACTION
2008-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
TOLECTIN DS · ReferenceDiscontinued
TOLMETIN SODIUM EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
Approval history
2000-12-19Manufacturing (CMC) · Supplement 49 · standardAP
2000-08-25Manufacturing (CMC) · Supplement 48 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 46 · standardAP
1993-03-18Manufacturing (CMC) · Supplement 44 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 43 · standardAP
1991-10-02Manufacturing (CMC) · Supplement 42 · standardAP
1991-07-11Manufacturing (CMC) · Supplement 40 · standardAP
1991-03-25Labeling · Supplement 41 · standardAP
1989-12-18Manufacturing (CMC) · Supplement 39 · standardAP
1989-10-17Manufacturing (CMC) · Supplement 38 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 32 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 35 · standardAP
1988-04-29Efficacy · Supplement 12 · standardAP
1987-12-02Manufacturing (CMC) · Supplement 31 · standardAP
1986-07-31Manufacturing (CMC) · Supplement 30 · standardAP
1986-07-31Manufacturing (CMC) · Supplement 29 · standardAP
1985-12-11Labeling · Supplement 28 · standardAP
1985-12-11Labeling · Supplement 26 · standardAP
1985-12-11Labeling · Supplement 27 · standardAP
1985-02-07Labeling · Supplement 25 · standardAP
1985-01-18Labeling · Supplement 21 · standardAP
1985-01-18Labeling · Supplement 7 · standardAP
1985-01-15Manufacturing (CMC) · Supplement 22 · standardAP
1985-01-15Manufacturing (CMC) · Supplement 9 · standardAP
1984-10-05Manufacturing (CMC) · Supplement 24 · standardAP
1984-05-03Manufacturing (CMC) · Supplement 23 · standardAP
1983-06-16Manufacturing (CMC) · Supplement 8 · standardAP
1983-05-25Manufacturing (CMC) · Supplement 19 · standardAP
1983-04-06Manufacturing (CMC) · Supplement 20 · standardAP
1983-01-31Labeling · Supplement 17 · standardAP
1983-01-31Labeling · Supplement 18 · standardAP
1982-07-27Manufacturing (CMC) · Supplement 6 · standardAP
1982-07-12Manufacturing (CMC) · Supplement 5 · standardAP
1981-12-21Manufacturing (CMC) · Supplement 3 · standardAP
1981-06-12Manufacturing (CMC) · Supplement 1 · standardAP
1981-04-01Manufacturing (CMC) · Supplement 4 · 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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