APPLICATION
NDA016769
TYPE
NDA
ORIGINAL APPROVAL
1970-01-15
LATEST ACTION
2001-01-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
URISPASDiscontinued
FLAVOXATE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
2001-01-03Manufacturing (CMC) · Supplement 33 · standardAP
2000-04-21Manufacturing (CMC) · Supplement 32 · standardAP
1999-10-29Manufacturing (CMC) · Supplement 31 · standardAP
1996-03-19Manufacturing (CMC) · Supplement 30 · standardAP
1994-09-27Manufacturing (CMC) · Supplement 29 · standardAP
1985-09-18Labeling · Supplement 25 · standardAP
1984-01-04Manufacturing (CMC) · Supplement 27 · standardAP
1982-10-08Labeling · Supplement 26 · standardAP
1979-05-29Labeling · Supplement 24 · standardAP
1979-01-04Labeling · Supplement 23 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 22 · standardAP
1978-05-15Manufacturing (CMC) · Supplement 21 · standardAP
1977-07-13Labeling · Supplement 20 · standardAP
1977-07-13Labeling · Supplement 19 · standardAP
1977-04-27Manufacturing (CMC) · Supplement 18 · standardAP
1976-09-24Labeling · Supplement 17 · standardAP
1976-09-24Labeling · Supplement 16 · standardAP
1976-08-10Manufacturing (CMC) · Supplement 14 · standardAP
1976-06-18Labeling · Supplement 13 · standardAP
1976-04-19Labeling · Supplement 12 · standardAP
1976-01-09Manufacturing (CMC) · Supplement 11 · standardAP
1975-07-25Manufacturing (CMC) · Supplement 10 · standardAP
1970-01-15Type 1 - New Molecular Entity · Original · 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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