APPLICATION
NDA017661
TYPE
NDA
ORIGINAL APPROVAL
1977-02-25
LATEST ACTION
2002-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TAVIST-1Discontinued
CLEMASTINE FUMARATE 1.34MG · TABLET · ORAL
TAVIST-1Discontinued
CLEMASTINE FUMARATE 1.34MG · TABLET · ORAL
TAVIST · ReferenceDiscontinued
CLEMASTINE FUMARATE 2.68MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-02-11Manufacturing (CMC) · Supplement 51 · standardAP
1996-10-31Efficacy · Supplement 48 · standardAP
1996-06-06Manufacturing (CMC) · Supplement 49 · standardAP
1995-11-07Manufacturing (CMC) · Supplement 45 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 47 · standardAP
1995-10-17Manufacturing (CMC) · Supplement 46 · standardAP
1995-02-03Labeling · Supplement 43 · standardAP
1994-07-21Manufacturing (CMC) · Supplement 42 · standardAP
1994-06-08Manufacturing (CMC) · Supplement 44 · standardAP
1993-05-21Manufacturing (CMC) · Supplement 41 · standardAP
1993-04-22Manufacturing (CMC) · Supplement 40 · standardAP
1992-09-08Manufacturing (CMC) · Supplement 34 · standardAP
1992-09-04Manufacturing (CMC) · Supplement 31 · standardAP
1992-08-21Efficacy · Supplement 26 · standardAP
1992-08-07Labeling · Supplement 38 · standardAP
1992-07-22Labeling · Supplement 36 · standardAP
1992-04-23Manufacturing (CMC) · Supplement 33 · standardAP
1991-03-04Manufacturing (CMC) · Supplement 32 · standardAP
1991-02-21Manufacturing (CMC) · Supplement 35 · standardAP
1987-12-04Manufacturing (CMC) · Supplement 30 · standardAP
1986-04-16Manufacturing (CMC) · Supplement 28 · standardAP
1986-04-15Manufacturing (CMC) · Supplement 24 · standardAP
1983-03-01Manufacturing (CMC) · Supplement 23 · standardAP
1981-07-17Manufacturing (CMC) · Supplement 21 · standardAP
1981-07-15Manufacturing (CMC) · Supplement 22 · standardAP
1980-10-14Manufacturing (CMC) · Supplement 14 · standardAP
1980-05-01Manufacturing (CMC) · Supplement 19 · standardAP
1980-04-17Manufacturing (CMC) · Supplement 17 · standardAP
1980-04-01Manufacturing (CMC) · Supplement 18 · standardAP
1979-04-20Manufacturing (CMC) · Supplement 15 · standardAP
1979-04-20Labeling · Supplement 16 · standardAP
1979-03-16Labeling · Supplement 6 · standardAP
1979-03-16Manufacturing (CMC) · Supplement 2 · standardAP
1979-03-16Efficacy · Supplement 5 · standardAP
1978-08-17Manufacturing (CMC) · Supplement 13 · standardAP
1978-08-14Labeling · Supplement 11 · standardAP
1978-08-14Manufacturing (CMC) · Supplement 10 · standardAP
1978-08-11Manufacturing (CMC) · Supplement 12 · standardAP
1978-05-30Manufacturing (CMC) · Supplement 8 · standardAP
1978-05-30Manufacturing (CMC) · Supplement 9 · 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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