APPLICATION
NDA012542
TYPE
NDA
ORIGINAL APPROVAL
1960-12-21
LATEST ACTION
1985-03-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TANDEARILDiscontinued
OXYPHENBUTAZONE 100MG · TABLET · ORAL
Approval history
1985-03-25Labeling · Supplement 56 · standardAP
1984-08-13Manufacturing (CMC) · Supplement 55 · standardAP
1983-02-25Manufacturing (CMC) · Supplement 52 · standardAP
1982-09-14Manufacturing (CMC) · Supplement 51 · standardAP
1982-09-03Manufacturing (CMC) · Supplement 47 · standardAP
1980-07-25Manufacturing (CMC) · Supplement 50 · standardAP
1979-09-06Labeling · Supplement 49 · standardAP
1979-08-08Manufacturing (CMC) · Supplement 48 · standardAP
1979-04-26Manufacturing (CMC) · Supplement 43 · standardAP
1979-04-26Manufacturing (CMC) · Supplement 40 · standardAP
1979-02-09Manufacturing (CMC) · Supplement 41 · standardAP
1978-11-08Manufacturing (CMC) · Supplement 46 · standardAP
1978-02-28Labeling · Supplement 42 · standardAP
1978-01-05Labeling · Supplement 37 · standardAP
1977-12-16Labeling · Supplement 45 · standardAP
1977-12-16Labeling · Supplement 44 · standardAP
1977-11-29Manufacturing (CMC) · Supplement 39 · standardAP
1977-04-29Manufacturing (CMC) · Supplement 36 · standardAP
1960-12-21Type 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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