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FDA NDA · NDA020124

DIAZEPAM

Sponsor: US ARMY

APPLICATION
NDA020124
TYPE
NDA
ORIGINAL APPROVAL
1990-12-05
LATEST ACTION
2023-01-13
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIAZEPAMDiscontinued
DIAZEPAM 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2023-01-13Labeling · Supplement 34 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 33 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 32 · standard — Label ↗AP
2002-10-31Manufacturing (CMC) · Supplement 11 · standardAP
2002-06-07Manufacturing (CMC) · Supplement 10 · standardAP
2002-04-03Manufacturing (CMC) · Supplement 9 · standardAP
2002-03-25Manufacturing (CMC) · Supplement 8 · standardAP
2001-01-23Manufacturing (CMC) · Supplement 7 · standardAP
2000-05-16Manufacturing (CMC) · Supplement 6 · standardAP
1999-10-28Manufacturing (CMC) · Supplement 5 · standardAP
1997-04-15Manufacturing (CMC) · Supplement 4 · standardAP
1996-09-11Manufacturing (CMC) · Supplement 3 · standardAP
1995-12-11Manufacturing (CMC) · Supplement 2 · standardAP
1992-08-24Manufacturing (CMC) · Supplement 1 · standardAP
1990-12-05Type 3 - New Dosage Form · 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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