Tranmep

As of Nov 13, 2026, NDA 16249 (Tranmep), held by Solvay, was first approved by FDA on Jan 27, 1967, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1967
Review: Standard
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Jan 27, 1967	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tranmep400MG · tablet;oral	Meprobamate	Discontinued

All 12 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 31, 1975	Supplement 25REMS · Standard review	Approved	None posted
Jan 29, 1975	Supplement 56Labeling · Standard review	Approved	None posted
Jan 14, 1975	Supplement 55Labeling · Standard review	Approved	None posted
Jan 14, 1975	Supplement 54Manufacturing · Standard review	Approved	None posted
Sep 26, 1974	Supplement 53Labeling · Standard review	Approved	None posted
Sep 17, 1974	Supplement 52Manufacturing · Standard review	Approved	None posted
Sep 4, 1974	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 27, 1974	Supplement 51Labeling · Standard review	Approved	None posted
Jul 19, 1974	Supplement 47Manufacturing · Standard review	Approved	None posted
May 30, 1974	Supplement 43REMS · Standard review	Approved	None posted
May 6, 1974	Supplement 44Manufacturing · Standard review	Approved	None posted
Jan 27, 1967	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 16249
Drugs@FDA: Overview at FDA
Company: Solvay

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