Meprobamate

NDA 14474, held by Stanlabs Pharm. Meprobamate.

As of Nov 13, 2026, NDA 14474 (Meprobamate), held by Stanlabs Pharm, was not approved, with 6 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 6
Complete response letters: 0

Products

2 strengths and forms

Product	Active ingredient	Marketing
Meprobamate200MG · tablet;oral	Meprobamate	Discontinued
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 6 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 30, 1979	Supplement 18Labeling	Approved	None posted
Apr 4, 1979	Supplement 19Labeling	Approved	None posted
May 15, 1978	Supplement 17Labeling	Approved	None posted
Jan 26, 1977	Supplement 12Manufacturing	Approved	None posted
Jan 26, 1977	Supplement 15Manufacturing	Approved	None posted
Jan 26, 1977	Supplement 16Labeling	Approved	None posted

Identifiers

Application: NDA 14474
Drugs@FDA: Overview at FDA
Company: Stanlabs Pharm

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