Meprobamate

NDA 14601, held by Pvt Form. Meprobamate.

As of Nov 13, 2026, NDA 14601 (Meprobamate), held by Pvt Form, was not approved, with 10 approved supplements and 0 published complete response letters.

First approved: Not approved
Supplements approved: 10
Complete response letters: 0

Products

1 strengths and forms

Product	Active ingredient	Marketing
Meprobamate400MG · tablet;oral	Meprobamate	Discontinued

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 7, 1979	Supplement 27Labeling	Approved	None posted
Feb 2, 1979	Supplement 26Labeling	Approved	None posted
Jan 12, 1979	Supplement 25Labeling	Approved	None posted
Dec 11, 1978	Supplement 24Labeling	Approved	None posted
Aug 4, 1978	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 4, 1978	Supplement 22Labeling	Approved	None posted
Jun 27, 1977	Supplement 21Labeling	Approved	None posted
Jun 6, 1977	Supplement 20Labeling	Approved	None posted
May 25, 1977	Supplement 19Labeling	Approved	None posted
Feb 21, 1975	Supplement 15REMS · Standard review	Approved	None posted

Identifiers

Application: NDA 14601
Drugs@FDA: Overview at FDA
Company: PVT FORM

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