Flurazepam Hydrochloride

ANDA 72368, held by Chartwell Rx. Flurazepam Hydrochloride.

First approved: Mar 30, 1989
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Mar 30, 1989	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Flurazepam Hydrochloride15MG · capsule;oral	Flurazepam Hydrochloride	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 17, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Feb 8, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Feb 6, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Dec 16, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Jul 17, 1998	Supplement 4Manufacturing	Approved	None posted
May 23, 1997	Supplement 3Manufacturing	Approved	None posted
Jun 23, 1993	Supplement 2Labeling	Approved	None posted
May 9, 1989	Supplement 1Labeling	Approved	None posted
Mar 30, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72368
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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