Centrax

NDA 18144, held by Parke Davis. Prazepam.

As of Nov 13, 2026, NDA 18144 (Centrax), held by Parke Davis, was first approved by FDA on Nov 30, 1979, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 30, 1979
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Nov 30, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


Centrax5MG · capsule;oral	Prazepam	Discontinued
Centrax10MG · capsule;oral	Prazepam	Discontinued
Centrax20MG · capsule;oral	Prazepam	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Apr 26, 1996	Supplement 9Labeling	Approved	None posted
Apr 26, 1996	Supplement 11Labeling	Approved	None posted
Apr 26, 1996	Supplement 13Labeling	Approved	None posted
Apr 26, 1996	Supplement 15Labeling · Standard review	Approved	None posted
Apr 26, 1996	Supplement 16Labeling · Standard review	Approved	None posted
May 1, 1984	Supplement 8Labeling	Approved	None posted
May 27, 1980	Supplement 1Labeling	Approved	None posted
Nov 30, 1979	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 18144
Drugs@FDA: Overview at FDA
Company: Parke-Davis

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