Crinone

NDA 20756, held by Watson Labs Inc. Progesterone.

As of Nov 13, 2026, NDA 20756 (Crinone), held by Watson Labs Inc, was first approved by FDA on May 13, 1997, with 8 approved supplements and 0 published complete response letters.

First approved: May 13, 1997
Review: Priority
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
May 13, 1997	Original applicationNew dosage form · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Crinone8% · gel;vaginal	Progesterone	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Sep 17, 2003	Supplement 12Labeling · Standard review	Approved	Letter
Apr 20, 2001	Supplement 10Manufacturing · Priority review	Approved	Letter
Apr 3, 2001	Supplement 9Labeling · Standard review	Approved	Letter
Dec 16, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
May 11, 1998	Supplement 6Labeling · Standard review	Approved	None posted
Feb 17, 1998	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 22, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 11, 1997	Supplement 5Manufacturing · Priority review	Approved	None posted
May 13, 1997	Original applicationNew dosage form · Priority review	Approved	Review

Identifiers

Application: NDA 20756
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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