Maolate

NDA 14217, held by Pamlab LLC. Chlorphenesin Carbamate.

As of Nov 14, 2026, NDA 14217 (Maolate), held by Pamlab LLC, was first approved by FDA on Jun 14, 1965, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 14, 1965
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 14, 1965	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Maolate400MG · tablet;oral	Chlorphenesin Carbamate	Discontinued

All 3 submissions, including labeling and manufacturing supplements


May 15, 1981	Supplement 21Labeling	Approved	None posted
Nov 24, 1975	Supplement 18Labeling	Approved	None posted
Jun 14, 1965	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 14217
Drugs@FDA: Overview at FDA
Company: PAMLAB LLC

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