APPLICATION
NDA017628
TYPE
NDA
ORIGINAL APPROVAL
1976-03-24
LATEST ACTION
2008-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TOLECTIN 600 · ReferenceDiscontinued
TOLMETIN SODIUM EQ 600MG BASE · TABLET · ORAL
TOLECTIN · ReferenceDiscontinued
TOLMETIN SODIUM EQ 200MG BASE · TABLET · ORAL
Approval history
2001-03-21Manufacturing (CMC) · Supplement 65 · standardAP
2001-02-26Manufacturing (CMC) · Supplement 64 · standardAP
1996-03-04Manufacturing (CMC) · Supplement 62 · standardAP
1993-06-11Manufacturing (CMC) · Supplement 60 · standardAP
1993-01-21Manufacturing (CMC) · Supplement 59 · standardAP
1992-10-02Manufacturing (CMC) · Supplement 58 · standardAP
1992-01-21Manufacturing (CMC) · Supplement 55 · standardAP
1991-07-11Manufacturing (CMC) · Supplement 56 · standardAP
1991-03-25Labeling · Supplement 57 · standardAP
1990-08-17Manufacturing (CMC) · Supplement 53 · standardAP
1989-12-18Manufacturing (CMC) · Supplement 54 · standardAP
1989-10-17Manufacturing (CMC) · Supplement 51 · standardAP
1989-07-28Manufacturing (CMC) · Supplement 41 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 45 · standardAP
1989-05-30Manufacturing (CMC) · Supplement 48 · standardAP
1989-03-08Efficacy · Supplement 31 · standardAP
1988-10-19Manufacturing (CMC) · Supplement 37 · standardAP
1988-04-29Efficacy · Supplement 24 · standardAP
1987-12-02Manufacturing (CMC) · Supplement 44 · standardAP
1986-07-31Manufacturing (CMC) · Supplement 42 · standardAP
1986-07-31Manufacturing (CMC) · Supplement 43 · standardAP
1985-12-11Labeling · Supplement 38 · standardAP
1985-12-11Labeling · Supplement 40 · standardAP
1985-12-11Labeling · Supplement 39 · standardAP
1985-02-07Labeling · Supplement 36 · standardAP
1985-01-18Labeling · Supplement 12 · standardAP
1985-01-18Labeling · Supplement 27 · standardAP
1985-01-18Labeling · Supplement 19 · standardAP
1985-01-18Labeling · Supplement 33 · standardAP
1984-12-11Manufacturing (CMC) · Supplement 20 · standardAP
1984-10-05Manufacturing (CMC) · Supplement 35 · standardAP
1984-05-03Manufacturing (CMC) · Supplement 34 · standardAP
1983-06-16Manufacturing (CMC) · Supplement 18 · standardAP
1983-05-25Manufacturing (CMC) · Supplement 30 · standardAP
1983-01-31Labeling · Supplement 28 · standardAP
1983-01-31Labeling · Supplement 29 · standardAP
1982-07-27Manufacturing (CMC) · Supplement 17 · standardAP
1982-07-22Manufacturing (CMC) · Supplement 13 · 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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