SUN PHARM INDS INC FDA Approval NDA 021951

NDA 021951

SUN PHARM INDS INC

FDA Drug Application

Application #021951

Documents

Letter2014-07-31
Letter2014-08-19
Letter2015-09-08
Letter2016-02-05
Label2012-05-29
Label2014-08-20
Letter2012-05-30
Letter2016-07-12
Label2014-07-31
Label2015-09-08
Review2013-05-24
Other2013-06-21
Letter2017-06-20
Letter2018-04-24
Letter2018-05-03
Label2018-05-04
Letter2018-09-13
Label2018-09-27
Letter2019-11-12
Label2019-11-14
Medication Guide2019-11-14
Letter2020-01-28
Letter2020-12-10
Letter2021-10-13
Letter2022-10-07

Application Sponsors

NDA 021951SUN PHARM INDS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001CAPSULE;ORAL10MG1ABSORICAISOTRETINOIN
002CAPSULE;ORAL20MG1ABSORICAISOTRETINOIN
003CAPSULE;ORAL30MG1ABSORICAISOTRETINOIN
004CAPSULE;ORAL40MG1ABSORICAISOTRETINOIN
005CAPSULE;ORAL25MG1ABSORICAISOTRETINOIN
006CAPSULE;ORAL35MG1ABSORICAISOTRETINOIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2012-05-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2014-08-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2014-10-20STANDARD
REMS; REMSSUPPL5AP2015-09-03N/A
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2015-12-23STANDARD
REMS; REMSSUPPL7AP2016-02-04N/A
REMS; REMSSUPPL8AP2016-07-08N/A
REMS; REMSSUPPL10AP2017-06-17N/A
LABELING; LabelingSUPPL11AP2018-05-02STANDARD
REMS; REMSSUPPL12AP2018-04-23N/A
LABELING; LabelingSUPPL13AP2019-11-07STANDARD
LABELING; LabelingSUPPL14AP2018-08-31STANDARD
REMS; REMSSUPPL15AP2020-01-24N/A
REMS; REMSSUPPL17AP2020-12-09N/A
REMS; REMSSUPPL18AP2021-10-08N/A
REMS; REMSSUPPL21AP2022-10-06N/A

Submissions Property Types

ORIG1Null6
SUPPL3Null0
SUPPL4Null0
SUPPL5Null6
SUPPL6Null0
SUPPL7Null15
SUPPL8Null6
SUPPL10Null6
SUPPL11Null6
SUPPL12Null7
SUPPL13Null33
SUPPL14Null6
SUPPL15Null6
SUPPL17Null15
SUPPL18Null6
SUPPL21Null15

TE Codes

001PrescriptionBX
002PrescriptionBX
003PrescriptionBX
004PrescriptionBX
005PrescriptionAB2
006PrescriptionAB2

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21951
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021951s013lbl.pdf#page=32"]
            [products] => [{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"20MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ABSORICA","activeIngredients":"ISOTRETINOIN","strength":"35MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/07\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021951s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021951s014lbl.pdf\"}]","notes":""},{"actionDate":"08\/31\/2018","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021951s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021951s011lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021951s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2015","submission":"SUPPL-5","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021951s005lbl.pdf\"}]","notes":""},{"actionDate":"08\/15\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021951s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"07\/30\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021951s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/25\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021951s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"20MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ABSORICA","submission":"ISOTRETINOIN","actionType":"35MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-11-07
        )

)
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