Crinone

Treats secondary amenorrhea. NDA 20701, held by Abbvie. Progesterone.

As of Nov 13, 2026, NDA 20701 (Crinone), held by Abbvie, was first approved by FDA on Jul 31, 1997, with 15 approved supplements and 0 published complete response letters.

First approved: Jul 31, 1997
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Assisted Reproductive Technology Crinone 8% is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency. Secondary Amenorrhea Crinone 4% is indicated for the treatment of secondary amenorrhea. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4%.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Jul 31, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Products

2 strengths and forms


Crinone4% · gel;vaginal	Progesterone	DiscontinuedReference drug
Crinone8% · gel;vaginal	Progesterone	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Sep 29, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Mar 4, 2014	Supplement 27Manufacturing · Standard review	Approved	None posted
Aug 21, 2013	Supplement 26Manufacturing · Standard review	Approved	Label
Dec 8, 2011	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 8, 2011	Supplement 21Labeling · Standard review	Approved	Letter Label
Dec 8, 2011	Supplement 23Labeling · Standard review	Approved	Letter Label
Mar 23, 2005	Supplement 14Labeling · Standard review	Approved	Letter Label
Nov 12, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Sep 17, 2003	Supplement 11Labeling · Standard review	Approved	Letter
Apr 20, 2001	Supplement 9Manufacturing · Standard review	Approved	Review Letter
Apr 3, 2001	Supplement 7Labeling · Standard review	Approved	Letter
Dec 16, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
May 11, 1998	Supplement 5Labeling · Standard review	Approved	None posted
Feb 17, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 11, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 31, 1997	Original applicationNew dosage form · Standard review	Approved	Review

Identifiers

Application: NDA 20701
Drugs@FDA: Overview at FDA
Company: AbbVie

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