Menopur

BLA 21663, held by Ferring. Menotropins (Fsh;Lh).

First approved: Oct 29, 2004
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
Feb 19, 2014	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 29, 2004	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Menopur75 IU/VIAL;75 IU/VIAL · injectable;subcutaneous	Menotropins (Fsh;Lh)	Rx

All 9 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jul 8, 2016	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 20, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 11, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Feb 19, 2014	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 11, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Jan 24, 2013	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 20, 2006	Supplement 1Labeling · Standard review	Approved	Label Letter
Mar 20, 2006	Supplement 2Manufacturing · Standard review	Approved	Label Letter
Oct 29, 2004	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: BLA 21663
Drugs@FDA: Overview at FDA
Company: Ferring Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters