Menrium 5-2, Menrium 5-4, Menrium 10-4

NDA 14740, held by Roche. Chlordiazepoxide; Estrogens, Esterified.

As of Nov 13, 2026, NDA 14740 (Menrium 5-2, Menrium 5-4, Menrium 10-4), held by Roche, was first approved by FDA on Jul 28, 1966, with 17 approved supplements and 0 published complete response letters.

First approved: Jul 28, 1966
Review: Standard
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Mar 27, 1996	Supplement 34Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 37Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 38Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 40Efficacy (new indication or use)	Approved	None posted
Mar 6, 1980	Supplement 41Efficacy (new indication or use)	Approved	None posted
Oct 6, 1978	Supplement 36Efficacy (new indication or use)	Approved	None posted
Jul 28, 1966	Original applicationNew combination · Standard review	Approved	None posted

Products

3 strengths and forms

Product	Active ingredient	Marketing
Menrium 5-25MG;0.2MG · tablet;oral	Chlordiazepoxide; Estrogens, Esterified	Discontinued
Menrium 5-45MG;0.4MG · tablet;oral	Chlordiazepoxide; Estrogens, Esterified	Discontinued
Menrium 10-410MG;0.4MG · tablet;oral	Chlordiazepoxide; Estrogens, Esterified	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 27, 1996	Supplement 19Labeling	Approved	None posted
Mar 27, 1996	Supplement 30Labeling	Approved	None posted
Mar 27, 1996	Supplement 31Labeling	Approved	None posted
Mar 27, 1996	Supplement 34Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 37Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 38Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 40Efficacy (new indication or use)	Approved	None posted
Mar 27, 1996	Supplement 42Labeling	Approved	None posted
Mar 27, 1996	Supplement 48Labeling	Approved	None posted
Mar 27, 1996	Supplement 54Labeling	Approved	None posted
Mar 1, 1989	Supplement 51Labeling	Approved	None posted
Mar 1, 1989	Supplement 52Labeling	Approved	None posted
Mar 1, 1989	Supplement 53Labeling	Approved	None posted
Jun 24, 1983	Supplement 46Labeling	Approved	None posted
Jun 24, 1983	Supplement 47Labeling	Approved	None posted
Mar 6, 1980	Supplement 41Efficacy (new indication or use)	Approved	None posted
Oct 6, 1978	Supplement 36Efficacy (new indication or use)	Approved	None posted
Jul 28, 1966	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 14740
Drugs@FDA: Overview at FDA
Company: Roche

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