← FDA DRUG APPROVALS

FDA NDA · NDA020648

DIAZEPAM

Sponsor: BAUSCH

APPLICATION
NDA020648
TYPE
NDA
ORIGINAL APPROVAL
1997-07-29
LATEST ACTION
2023-07-10
ROUTE
RECTAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription, Discontinued

Products

DIASTAT ACUDIAL · ReferencePrescription
DIAZEPAM 20MG/4ML (5MG/ML) · GEL · RECTAL
DIASTAT · ReferenceDiscontinued
DIAZEPAM 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · RECTAL
DIASTAT · ReferenceDiscontinued
DIAZEPAM 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · RECTAL
DIASTAT ACUDIAL · ReferencePrescription
DIAZEPAM 10MG/2ML (5MG/ML) · GEL · RECTAL
DIASTAT · ReferenceDiscontinued
DIAZEPAM 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · RECTAL
DIASTAT · ReferenceDiscontinued
DIAZEPAM 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · RECTAL
DIASTAT · ReferencePrescription
DIAZEPAM 2.5MG/0.5ML (5MG/ML) · GEL · RECTAL

Approval history

2023-07-10Manufacturing (CMC) · Supplement 24 — Label ↗AP
2023-01-13Labeling · Supplement 23 · standard — Letter ↗AP
2021-03-25Labeling · Supplement 22 · standard — Letter ↗AP
2021-02-05Labeling · Supplement 21 · standard — Letter ↗AP
2016-12-16Labeling · Supplement 14 · standard — Label ↗AP
2016-10-27Labeling · Supplement 13 · standard — Letter ↗AP
2014-12-16Labeling · Supplement 12 · standard — Letter ↗AP
2013-08-29Labeling · Supplement 9 · standard — Label ↗AP
2005-09-15Manufacturing (CMC) · Supplement 8 · standard — Patient Package Insert ↗AP
2002-06-18Manufacturing (CMC) · Supplement 5 · standardAP
2001-04-11Labeling · Supplement 2 · standard — Review ↗AP
2000-10-17Manufacturing (CMC) · Supplement 4 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 3 · standardAP
1998-08-25Manufacturing (CMC) · Supplement 1 · standardAP
1997-07-29Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗AP
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 →