Serophene

NDA 18361, held by Emd Serono. Clomiphene Citrate.

As of Nov 13, 2026, NDA 18361 (Serophene), held by Emd Serono, was first approved by FDA on Mar 22, 1982, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 22, 1982
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 22, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Serophene50MG · tablet;oral	Clomiphene Citrate	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Jul 31, 2003	Supplement 29Labeling	Approved	None posted
Aug 13, 2002	Supplement 28Labeling	Approved	None posted
Aug 14, 2001	Supplement 27Labeling	Approved	None posted
Feb 1, 2001	Supplement 26Manufacturing	Approved	None posted
Apr 2, 1996	Supplement 24Labeling	Approved	None posted
Dec 30, 1994	Supplement 22Manufacturing	Approved	None posted
Aug 21, 1985	Supplement 1Manufacturing	Approved	None posted
Mar 22, 1982	Original application	Approved	None posted

Identifiers

Application: NDA 18361
Drugs@FDA: Overview at FDA
Company: EMD Serono, Inc.

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