← FDA DRUG APPROVALS

FDA NDA · NDA013263

VALIUM

diazepam

Sponsor: WAYLIS THERAP

APPLICATION
NDA013263
TYPE
NDA
ORIGINAL APPROVAL
1963-11-15
LATEST ACTION
2024-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VALIUM · ReferencePrescription
DIAZEPAM 10MG · TABLET · ORAL
VALIUM · ReferencePrescription
DIAZEPAM 5MG · TABLET · ORAL
VALIUM · ReferencePrescription
DIAZEPAM 2MG · TABLET · ORAL

Approval history

2024-03-19Labeling · Supplement 101 · standard — Letter ↗AP
2023-10-11Labeling · Supplement 100 · standard — Label ↗AP
2023-03-14Labeling · Supplement 98 · standard — Label ↗AP
2023-01-13Labeling · Supplement 97 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 96 · 901 required — Letter ↗AP
2016-12-16Labeling · Supplement 94 · 901 required — Label ↗AP
2015-07-30Manufacturing (CMC) · Supplement 93 · standardAP
2013-10-22Labeling · Supplement 92 · standard — Letter ↗AP
2013-04-19Manufacturing (CMC) · Supplement 91 · standardAP
2008-05-12Labeling · Supplement 80 · standard — Letter ↗AP
2008-05-12Labeling · Supplement 83 · standard — Letter ↗AP
2002-02-12Manufacturing (CMC) · Supplement 86 · standard — Review ↗AP
2002-02-07Labeling · Supplement 72 — Letter ↗AP
2002-02-07Labeling · Supplement 75 · standard — Review ↗AP
2001-11-08Manufacturing (CMC) · Supplement 85 · standardAP
2001-10-25Manufacturing (CMC) · Supplement 84 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 82 · standard — Review ↗AP
2000-08-30Manufacturing (CMC) · Supplement 81 · standard — Review ↗AP
1998-09-04Manufacturing (CMC) · Supplement 79 · standardAP
1997-11-05Manufacturing (CMC) · Supplement 77 · standardAP
1997-09-19Manufacturing (CMC) · Supplement 78 · standardAP
1997-09-05Manufacturing (CMC) · Supplement 76 · standardAP
1989-10-26Manufacturing (CMC) · Supplement 74 · standardAP
1988-11-08Manufacturing (CMC) · Supplement 73 · standardAP
1988-01-20Manufacturing (CMC) · Supplement 71 · standardAP
1986-08-27Manufacturing (CMC) · Supplement 70 · standardAP
1985-04-16Manufacturing (CMC) · Supplement 69 · standardAP
1984-01-13Manufacturing (CMC) · Supplement 68 · standardAP
1984-01-13Labeling · Supplement 67AP
1983-03-04Manufacturing (CMC) · Supplement 55 · standardAP
1983-01-20Manufacturing (CMC) · Supplement 65 · standardAP
1983-01-20Manufacturing (CMC) · Supplement 66 · standardAP
1982-12-10Manufacturing (CMC) · Supplement 64 · standardAP
1982-11-30Manufacturing (CMC) · Supplement 63 · standardAP
1982-10-18Manufacturing (CMC) · Supplement 59 · standardAP
1982-10-18Manufacturing (CMC) · Supplement 61 · standardAP
1982-10-18Labeling · Supplement 62AP
1982-10-18Manufacturing (CMC) · Supplement 60 · standardAP
1982-08-11Manufacturing (CMC) · Supplement 57 · standardAP
1982-05-11Manufacturing (CMC) · Supplement 56 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →