Miradon

NDA 10909, held by Schering. Anisindione.

As of Nov 14, 2026, NDA 10909 (Miradon), held by Schering, was first approved by FDA on Apr 5, 1957, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 5, 1957
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 5, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miradon50MG · tablet;oral	Anisindione	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 7, 2007	Supplement 7Labeling	Approved	None posted
Feb 6, 2002	Supplement 13Labeling · Standard review	Approved	Letter
Jan 12, 1995	Supplement 11Manufacturing · Standard review	Approved	None posted
Dec 30, 1994	Supplement 10Labeling · Standard review	Approved	None posted
Apr 5, 1989	Supplement 9Labeling	Approved	None posted
Aug 8, 1986	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 18, 1981	Supplement 5Labeling	Approved	None posted
Nov 18, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 5, 1957	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 10909
Drugs@FDA: Overview at FDA
Company: Schering Corporation

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