APPLICATION
NDA013731
TYPE
NDA
ORIGINAL APPROVAL
1969-10-24
LATEST ACTION
1995-02-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BILOPAQUEDiscontinued
TYROPANOATE SODIUM 750MG · CAPSULE · ORAL
Approval history
1995-02-22Manufacturing (CMC) · Supplement 30 · standardAP
1991-02-21Manufacturing (CMC) · Supplement 31 · standardAP
1990-02-21Manufacturing (CMC) · Supplement 29 · standardAP
1988-02-22Labeling · Supplement 28 · standardAP
1987-05-20Manufacturing (CMC) · Supplement 27 · standardAP
1986-07-18Labeling · Supplement 26 · standardAP
1986-07-11Manufacturing (CMC) · Supplement 25 · standardAP
1984-11-07Labeling · Supplement 24 · standardAP
1984-07-11Manufacturing (CMC) · Supplement 22 · standardAP
1984-02-01Labeling · Supplement 21 · standardAP
1982-06-30Labeling · Supplement 20 · standardAP
1982-02-08Manufacturing (CMC) · Supplement 17 · standardAP
1980-01-25Manufacturing (CMC) · Supplement 19 · standardAP
1979-10-29Manufacturing (CMC) · Supplement 18 · standardAP
1979-05-14Manufacturing (CMC) · Supplement 16 · standardAP
1978-12-28Manufacturing (CMC) · Supplement 15 · standardAP
1978-10-30Manufacturing (CMC) · Supplement 14 · standardAP
1977-06-15Manufacturing (CMC) · Supplement 13 · standardAP
1977-06-08Labeling · Supplement 12 · standardAP
1976-05-11Manufacturing (CMC) · Supplement 10 · standardAP
1969-10-24Type 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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