Metrodin, Fertinex

NDA 19415, held by Serono. Urofollitropin.

As of Nov 13, 2026, NDA 19415 (Metrodin, Fertinex), held by Serono, was first approved by FDA on Sep 18, 1986, with 24 approved supplements and 0 published complete response letters.

First approved: Sep 18, 1986
Review: Standard
Supplements approved: 24
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below


Aug 23, 1996	Supplement 9Efficacy (new indication or use)	Approved	None posted
Aug 29, 1995	Supplement 13Efficacy (new indication or use)	Approved	None posted
Mar 1, 1988	Supplement 1Efficacy (new indication or use)	Approved	None posted
Sep 18, 1986	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

4 strengths and forms


Metrodin75 IU/AMP · injectable;intramuscular	Urofollitropin	Discontinued
Metrodin150 IU/AMP · injectable;intramuscular	Urofollitropin	Discontinued
Fertinex150 IU/AMP · injectable;subcutaneous	Urofollitropin	Discontinued
Fertinex75 IU/AMP · injectable;subcutaneous	Urofollitropin	Discontinued

All 25 submissions, including labeling and manufacturing supplements


Apr 15, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Dec 28, 2000	Supplement 28Manufacturing · Standard review	Approved	None posted
Aug 31, 2000	Supplement 26Manufacturing · Standard review	Approved	None posted
Jul 18, 2000	Supplement 25Manufacturing · Standard review	Approved	None posted
Jun 19, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Jan 21, 2000	Supplement 24Manufacturing · Standard review	Approved	None posted
Nov 24, 1999	Supplement 21Labeling · Standard review	Approved	None posted
May 20, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Apr 1, 1999	Supplement 22Manufacturing · Standard review	Approved	None posted
Apr 15, 1998	Supplement 18Manufacturing · Standard review	Approved	None posted
Feb 18, 1998	Supplement 17Manufacturing · Standard review	Approved	None posted
Aug 23, 1996	Supplement 9Efficacy (new indication or use)	Approved	None posted
Aug 22, 1996	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 22, 1996	Supplement 15Manufacturing · Standard review	Approved	None posted
Aug 29, 1995	Supplement 13Efficacy (new indication or use)	Approved	None posted
Jul 12, 1995	Supplement 14Labeling · Standard review	Approved	None posted
May 31, 1994	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 28, 1994	Supplement 10Labeling	Approved	None posted
Jan 24, 1994	Supplement 11Labeling · Standard review	Approved	None posted
Dec 6, 1993	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 17, 1991	Supplement 6Manufacturing · Standard review	Approved	None posted
Mar 14, 1990	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 25, 1988	Supplement 2Labeling	Approved	None posted
Mar 1, 1988	Supplement 1Efficacy (new indication or use)	Approved	None posted
Sep 18, 1986	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 19415
Drugs@FDA: Overview at FDA
Company: Serono

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