NDA 020701

ALLERGAN

FDA Drug Application

Application #020701

Documents

• Letter: 2001-04-23
• Letter: 2003-09-29
• Letter: 2005-03-29
• Letter: 2011-12-14
• Letter: 2011-12-14
• Label: 2005-03-29
• Label: 2011-12-14
• Label: 2013-08-22
• Letter: 2001-04-11
• Letter: 2003-11-26
• Letter: 2011-12-14
• Label: 2011-12-14
• Label: 2011-12-14
• Review: 2003-08-08
• Review: 2007-11-19

Application Sponsors

NDA 020701

ALLERGAN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	GEL;VAGINAL	4%	1	CRINONE	PROGESTERONE
002	GEL;VAGINAL	8%	1	CRINONE	PROGESTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1997-07-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-11	STANDARD
LABELING; Labeling	SUPPL	5	AP	1998-05-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-12-16	STANDARD
LABELING; Labeling	SUPPL	7	AP	2001-04-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-20	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-09-17	STANDARD
LABELING; Labeling	SUPPL	12	AP	2003-11-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2005-03-23	STANDARD
LABELING; Labeling	SUPPL	20	AP	2011-12-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	2011-12-08	STANDARD
LABELING; Labeling	SUPPL	23	AP	2011-12-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2015-09-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2013-08-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2014-03-04	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	20	Null	15
SUPPL	21	Null	6
SUPPL	23	Null	15
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

ALLERGAN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20701
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CRINONE","activeIngredients":"PROGESTERONE","strength":"4%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"CRINONE","activeIngredients":"PROGESTERONE","strength":"8%","dosageForm":"GEL;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/21\/2013","submission":"SUPPL-26","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020701s026lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/08\/2011","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020701s020s021s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2011","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020701s020s021s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2011","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020701s020s021s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2005","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20701s014lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"CRINONE","submission":"PROGESTERONE","actionType":"4%","submissionClassification":"GEL;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"CRINONE","submission":"PROGESTERONE","actionType":"8%","submissionClassification":"GEL;VAGINAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-08-21
        )

)