← FDA DRUG APPROVALS

FDA NDA · NDA020701

CRINONE

progesterone

Sponsor: ABBVIE

APPLICATION
NDA020701
TYPE
NDA
ORIGINAL APPROVAL
1997-07-31
LATEST ACTION
2015-09-29
ROUTE
VAGINAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued, Prescription

Products

CRINONE · ReferenceDiscontinued
PROGESTERONE 4% · GEL · VAGINAL
CRINONE · ReferencePrescription
PROGESTERONE 8% · GEL · VAGINAL

Approval history

2015-09-29Manufacturing (CMC) · Supplement 24 · standardAP
2014-03-04Manufacturing (CMC) · Supplement 27 · standardAP
2013-08-21Manufacturing (CMC) · Supplement 26 · standard — Label ↗AP
2011-12-08Labeling · Supplement 20 · standard — Label ↗AP
2011-12-08Labeling · Supplement 23 · standard — Letter ↗AP
2011-12-08Labeling · Supplement 21 · standard — Letter ↗AP
2005-03-23Labeling · Supplement 14 · standard — Label ↗AP
2003-11-12Labeling · Supplement 12 · standard — Letter ↗AP
2003-09-17Labeling · Supplement 11 · standard — Letter ↗AP
2001-04-20Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2001-04-03Labeling · Supplement 7 · standard — Letter ↗AP
1998-12-16Manufacturing (CMC) · Supplement 6 · standardAP
1998-05-11Labeling · Supplement 5 · standardAP
1998-02-17Manufacturing (CMC) · Supplement 1 · standardAP
1997-12-11Manufacturing (CMC) · Supplement 4 · standardAP
1997-07-31Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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