Diastat, Diastat Acudial

Treats intermittent, stereotypic episodes of frequent seizure activity. NDA 20648, held by Bausch. Diazepam.

As of Nov 13, 2026, NDA 20648 (Diastat, Diastat Acudial), held by Bausch, was first approved by FDA on Jul 29, 1997, with 14 approved supplements and 0 published complete response letters.

First approved: Jul 29, 1997
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in patients with epilepsy 2 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jul 29, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Products

7 strengths and forms

Product	Active ingredient	Marketing
Diastat2.5MG/0.5ML (5MG/ML) · gel;rectal	Diazepam	RxReference drug
Diastat5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;rectal	Diazepam	DiscontinuedReference drug
Diastat10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;rectal	Diazepam	DiscontinuedReference drug
Diastat15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;rectal	Diazepam	DiscontinuedReference drug
Diastat20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · gel;rectal	Diazepam	DiscontinuedReference drug
Diastat Acudial20MG/4ML (5MG/ML) · gel;rectal	Diazepam	RxReference drug
Diastat Acudial10MG/2ML (5MG/ML) · gel;rectal	Diazepam	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 10, 2023	Supplement 24Manufacturing	Approved	Label Letter
Jan 13, 2023	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 25, 2021	Supplement 22Labeling · Standard review	Approved	Letter Label
Feb 5, 2021	Supplement 21Labeling · Standard review	Approved	Label Letter
Dec 16, 2016	Supplement 14Labeling · Standard review	Approved	Letter Label
Oct 27, 2016	Supplement 13Labeling · Standard review	Approved	Label Letter
Dec 16, 2014	Supplement 12Labeling · Standard review	Approved	Letter Label
Aug 29, 2013	Supplement 9Labeling · Standard review	Approved	Label Letter
Sep 15, 2005	Supplement 8Manufacturing · Standard review	Approved	Patient Package Insert Label Letter
Jun 18, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 11, 2001	Supplement 2Labeling · Standard review	Approved	Review Letter
Oct 17, 2000	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 31, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 25, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Jul 29, 1997	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20648
Drugs@FDA: Overview at FDA
Company: Bausch Health

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters