APPLICATION
ANDA074224
TYPE
ANDA
ORIGINAL APPROVAL
1994-06-01
LATEST ACTION
2023-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIAZOLAMDiscontinued
TRIAZOLAM 0.125MG · TABLET · ORAL
TRIAZOLAMDiscontinued
TRIAZOLAM 0.25MG · TABLET · ORAL
Approval history
2023-06-28Labeling · Supplement 12 · standardAP
2022-01-03Labeling · Supplement 10 · standardAP
2022-01-03Labeling · Supplement 11 · standardAP
2020-04-14Labeling · Supplement 9 · standardAP
2020-04-14Labeling · Supplement 7 · standardAP
2016-01-04Labeling · Supplement 6 · standardAP
2007-09-14Labeling · Supplement 5AP
1997-12-16Labeling · Supplement 3AP
1996-08-28Manufacturing (CMC) · Supplement 2AP
1994-12-13Manufacturing (CMC) · Supplement 1AP
1994-06-01OriginalAP
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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