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FDA NDA · NDA018276

ALPRAZOLAM

Sponsor: UPJOHN

APPLICATION
NDA018276
TYPE
NDA
ORIGINAL APPROVAL
1981-10-16
LATEST ACTION
2023-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

XANAX · ReferencePrescription
ALPRAZOLAM 0.5MG · TABLET · ORAL
XANAX · ReferencePrescription
ALPRAZOLAM 1MG · TABLET · ORAL
XANAX · ReferencePrescription
ALPRAZOLAM 0.25MG · TABLET · ORAL
XANAX · ReferencePrescription
ALPRAZOLAM 2MG · TABLET · ORAL

Approval history

2023-01-13Labeling · Supplement 59 · standard — Letter ↗AP
2021-03-01Labeling · Supplement 55 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 58 · 901 required — Letter ↗AP
2016-12-16Labeling · Supplement 52 · 901 required — Label ↗AP
2014-08-08Manufacturing (CMC) · Supplement 49 · standardAP
2011-08-23Labeling · Supplement 45 · unknown — Letter ↗AP
2011-06-01Labeling · Supplement 44 · unknown — Letter ↗AP
2004-04-02Labeling · Supplement 38 · standard — Review ↗AP
2004-04-02Labeling · Supplement 39 · standard — Review ↗AP
2002-11-07Manufacturing (CMC) · Supplement 37 · standardAP
2000-05-02Labeling · Supplement 35 · standard — Review ↗AP
1999-11-16Manufacturing (CMC) · Supplement 36 · standardAP
1998-11-24Labeling · Supplement 34 · standardAP
1996-12-20Labeling · Supplement 33 · standard — Review ↗AP
1996-04-18Labeling · Supplement 32 · standardAP
1994-06-22Manufacturing (CMC) · Supplement 25 · standardAP
1993-09-30Manufacturing (CMC) · Supplement 26 · standardAP
1993-09-14Labeling · Supplement 31 · standardAP
1993-05-21Manufacturing (CMC) · Supplement 27 · standardAP
1992-12-01Labeling · Supplement 28 · standardAP
1990-11-06Efficacy · Supplement 17AP
1990-11-06Labeling · Supplement 15AP
1990-10-23Labeling · Supplement 16AP
1990-10-22Labeling · Supplement 21AP
1989-03-24Manufacturing (CMC) · Supplement 22 · standardAP
1988-08-17Manufacturing (CMC) · Supplement 14 · standardAP
1988-08-03Labeling · Supplement 20AP
1988-07-26Manufacturing (CMC) · Supplement 19 · standardAP
1988-03-25Manufacturing (CMC) · Supplement 18 · standardAP
1987-12-08Labeling · Supplement 5AP
1987-02-11Labeling · Supplement 13AP
1987-01-28Labeling · Supplement 10AP
1987-01-12Labeling · Supplement 7AP
1986-07-16Manufacturing (CMC) · Supplement 12 · standardAP
1986-03-27Manufacturing (CMC) · Supplement 9 · standardAP
1985-11-27Manufacturing (CMC) · Supplement 8 · standardAP
1985-11-27Manufacturing (CMC) · Supplement 6 · standardAP
1983-12-08Labeling · Supplement 3AP
1983-11-18Manufacturing (CMC) · Supplement 2 · standardAP
1981-10-16Type 1 - New Molecular Entity · Original · standardAP
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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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