Pmb 400, Pmb 200

NDA 10971, held by Wyeth Ayerst. Estrogens, Conjugated; Meprobamate.

As of Nov 13, 2026, NDA 10971 (Pmb 400, Pmb 200), held by Wyeth Ayerst, was first approved by FDA on May 31, 1957, with 7 approved supplements and 0 published complete response letters.

First approved: May 31, 1957
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
May 31, 1957	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Pmb 4000.45MG;400MG · tablet;oral	Estrogens, Conjugated; Meprobamate	Discontinued
Pmb 2000.45MG;200MG · tablet;oral	Estrogens, Conjugated; Meprobamate	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 27, 1996	Supplement 48Manufacturing · Standard review	Approved	None posted
Dec 27, 1995	Supplement 46Manufacturing · Standard review	Approved	None posted
Sep 7, 1995	Supplement 42Labeling · Standard review	Approved	None posted
Feb 23, 1990	Supplement 44Manufacturing · Standard review	Approved	None posted
Dec 20, 1988	Supplement 43Manufacturing · Standard review	Approved	None posted
May 17, 1987	Supplement 41Manufacturing · Standard review	Approved	None posted
Apr 11, 1986	Supplement 39Labeling · Standard review	Approved	None posted
May 31, 1957	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 10971
Drugs@FDA: Overview at FDA
Company: Wyeth-Ayerst

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