Liquamar

NDA 11228, held by Organon USA Inc. Phenprocoumon.

As of Nov 13, 2026, NDA 11228 (Liquamar), held by Organon USA Inc, was first approved by FDA on Dec 30, 1957, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1957
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Dec 30, 1957	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Liquamar3MG · tablet;oral	Phenprocoumon	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Sep 1, 1992	Supplement 8Labeling	Approved	None posted
Nov 29, 1978	Supplement 6Labeling	Approved	None posted
Nov 29, 1978	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 30, 1957	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 11228
Drugs@FDA: Overview at FDA
Company: Organon USA

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