Exna

NDA 12489, held by Ah Robins Inc. Benzthiazide.

As of Nov 13, 2026, NDA 12489 (Exna), held by Ah Robins Inc, was first approved by FDA on Oct 14, 1960, with 18 approved supplements and 0 published complete response letters.

First approved: Oct 14, 1960
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Oct 14, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Exna50MG · tablet;oral	Benzthiazide	Discontinued

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Dec 1, 1994	Supplement 22Labeling · Standard review	Approved	None posted
Apr 11, 1986	Supplement 18Labeling · Standard review	Approved	None posted
Sep 13, 1983	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 10, 1982	Supplement 20Manufacturing · Standard review	Approved	None posted
Jul 15, 1982	Supplement 19Labeling · Standard review	Approved	None posted
Apr 12, 1982	Supplement 17Manufacturing · Standard review	Approved	None posted
Feb 17, 1981	Supplement 16Manufacturing · Standard review	Approved	None posted
Feb 13, 1981	Supplement 15Labeling · Standard review	Approved	None posted
Jan 27, 1981	Supplement 14Manufacturing · Standard review	Approved	None posted
Apr 18, 1979	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 18, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Apr 18, 1979	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 27, 1978	Supplement 10Manufacturing · Standard review	Approved	None posted
Apr 27, 1978	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 8, 1977	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 2, 1976	Supplement 7Manufacturing · Standard review	Approved	None posted
Apr 2, 1976	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 25, 1975	Supplement 4Labeling · Standard review	Approved	None posted
Oct 14, 1960	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 12489
Drugs@FDA: Overview at FDA
Company: A.H. Robins

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