ALLERGAN FDA Approval NDA 020701

NDA 020701

ALLERGAN

FDA Drug Application

Application #020701

Documents

Letter2001-04-23
Letter2003-09-29
Letter2005-03-29
Letter2011-12-14
Letter2011-12-14
Label2005-03-29
Label2011-12-14
Label2013-08-22
Letter2001-04-11
Letter2003-11-26
Letter2011-12-14
Label2011-12-14
Label2011-12-14
Review2003-08-08
Review2007-11-19

Application Sponsors

NDA 020701ALLERGAN

Marketing Status

Prescription001
Prescription002

Application Products

001GEL;VAGINAL4%1CRINONEPROGESTERONE
002GEL;VAGINAL8%1CRINONEPROGESTERONE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-07-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-12-11STANDARD
LABELING; LabelingSUPPL5AP1998-05-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-12-16STANDARD
LABELING; LabelingSUPPL7AP2001-04-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-04-20STANDARD
LABELING; LabelingSUPPL11AP2003-09-17STANDARD
LABELING; LabelingSUPPL12AP2003-11-12STANDARD
LABELING; LabelingSUPPL14AP2005-03-23STANDARD
LABELING; LabelingSUPPL20AP2011-12-08STANDARD
LABELING; LabelingSUPPL21AP2011-12-08STANDARD
LABELING; LabelingSUPPL23AP2011-12-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2015-09-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2013-08-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2014-03-04STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL4Null0
SUPPL6Null0
SUPPL9Null0
SUPPL20Null15
SUPPL21Null6
SUPPL23Null15
SUPPL24Null0
SUPPL26Null0
SUPPL27Null0

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
        )

)

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