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FDA NDA · NDA017892

TRIAZOLAM

Sponsor: PFIZER

APPLICATION
NDA017892
TYPE
NDA
ORIGINAL APPROVAL
1982-11-15
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

HALCION · ReferencePrescription
TRIAZOLAM 0.125MG · TABLET · ORAL
HALCION · ReferencePrescription
TRIAZOLAM 0.25MG · TABLET · ORAL
HALCIONDiscontinued
TRIAZOLAM 0.5MG · TABLET · ORAL

Approval history

2023-01-13Labeling · Supplement 57 · standard — Letter ↗AP
2021-10-27Labeling · Supplement 56 · standard — Label ↗AP
2021-02-05Labeling · Supplement 55 · 901 required — Letter ↗AP
2019-10-09Labeling · Supplement 50 · standard — Letter ↗AP
2019-02-06Labeling · Supplement 54 · 901 required — Label ↗AP
2016-12-16Labeling · Supplement 49 · 901 required — Label ↗AP
2015-12-15Manufacturing (CMC) · Supplement 48 · priorityAP
2014-09-18Labeling · Supplement 47 · standard — Letter ↗AP
2014-01-21Manufacturing (CMC) · Supplement 45 · priorityAP
2013-01-25Manufacturing (CMC) · Supplement 44 · priorityAP
2008-02-12Labeling · Supplement 38 · standard — Letter ↗AP
2003-06-25Labeling · Supplement 34 · standard — Letter ↗AP
1999-11-04Manufacturing (CMC) · Supplement 35 · priorityAP
1996-04-04Labeling · Supplement 33 · standardAP
1994-11-04Manufacturing (CMC) · Supplement 32 · priorityAP
1994-07-13Manufacturing (CMC) · Supplement 31 · priorityAP
1993-09-14Labeling · Supplement 30 · standardAP
1993-05-25Manufacturing (CMC) · Supplement 26 · priorityAP
1993-05-21Manufacturing (CMC) · Supplement 21 · priorityAP
1992-02-21Manufacturing (CMC) · Supplement 24 · priorityAP
1991-11-13Labeling · Supplement 23AP
1991-01-17Labeling · Supplement 22AP
1990-08-16Labeling · Supplement 19AP
1990-08-16Labeling · Supplement 17AP
1990-08-16Labeling · Supplement 18AP
1989-03-20Labeling · Supplement 16AP
1988-08-24Manufacturing (CMC) · Supplement 9 · priorityAP
1988-07-26Manufacturing (CMC) · Supplement 13 · priorityAP
1988-05-06Labeling · Supplement 15AP
1988-05-05Labeling · Supplement 14AP
1988-03-25Manufacturing (CMC) · Supplement 12 · priorityAP
1987-10-23Labeling · Supplement 7AP
1987-10-23Labeling · Supplement 11AP
1987-10-23Labeling · Supplement 8AP
1987-10-23Labeling · Supplement 10AP
1987-10-23Labeling · Supplement 2AP
1985-12-06Manufacturing (CMC) · Supplement 5 · priorityAP
1985-04-26Manufacturing (CMC) · Supplement 1 · priorityAP
1985-04-26Labeling · Supplement 4AP
1982-11-15Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
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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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