APPLICATION
NDA016118
TYPE
NDA
ORIGINAL APPROVAL
1970-05-27
LATEST ACTION
2003-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TESLACDiscontinued
TESTOLACTONE 250MG · TABLET · ORAL
TESLACDiscontinued
TESTOLACTONE 50MG · TABLET · ORAL
Approval history
2001-03-22Manufacturing (CMC) · Supplement 22 · standardAP
1999-08-24Labeling · Supplement 20 · standardAP
1999-02-25Manufacturing (CMC) · Supplement 21 · standardAP
1995-10-10Manufacturing (CMC) · Supplement 17 · standardAP
1995-08-28Manufacturing (CMC) · Supplement 19 · standardAP
1992-12-09Labeling · Supplement 18 · standardAP
1987-08-20Labeling · Supplement 14 · standardAP
1986-05-30Manufacturing (CMC) · Supplement 16 · standardAP
1985-07-03Manufacturing (CMC) · Supplement 15 · standardAP
1979-10-11Manufacturing (CMC) · Supplement 12 · standardAP
1979-04-27Manufacturing (CMC) · Supplement 13 · standardAP
1978-08-04Manufacturing (CMC) · Supplement 11 · standardAP
1978-01-16Manufacturing (CMC) · Supplement 10 · standardAP
1976-06-22REMS · Supplement 9 · standardAP
1976-05-06Manufacturing (CMC) · Supplement 8 · standardAP
1970-05-27Type 3 - New Dosage Form · 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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