DR REDDYS LABS SA FDA Approval NDA 020076

NDA 020076

DR REDDYS LABS SA

FDA Drug Application

Application #020076

Documents

Letter2002-07-12
Letter2005-11-30
Letter2016-07-07
Label2002-07-15
Label2014-07-29
Label2016-06-17
Label2016-07-08
Label2016-07-18
Letter1999-11-12
Letter2002-07-15
Letter2004-03-03
Letter2004-01-22
Letter2004-10-29
Letter2006-05-16
Letter2014-07-28
Letter2016-05-16
Letter2016-07-07
Label2002-07-12
Letter2017-07-25
Label2017-07-26
Letter2018-07-06
Label2018-07-06
Letter2019-02-01
Label2019-01-04

Application Sponsors

NDA 020076DR REDDYS LABS SA

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Over-the-counter004
Over-the-counter005
Over-the-counter006

Application Products

001Film, Extended Release; Transdermal7MG/24HR0HABITROLNICOTINE
002Film, Extended Release; Transdermal14MG/24HR0HABITROLNICOTINE
003Film, Extended Release; Transdermal21MG/24HR0HABITROLNICOTINE
004FILM, EXTENDED RELEASE;TRANSDERMAL7MG/24HR1HABITROLNICOTINE
005FILM, EXTENDED RELEASE;TRANSDERMAL14MG/24HR1HABITROLNICOTINE
006FILM, EXTENDED RELEASE;TRANSDERMAL21MG/24HR1HABITROLNICOTINE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1991-11-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1992-07-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1992-07-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1994-10-06STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-02-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-07-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-10-06STANDARD
EFFICACY; EfficacySUPPL11AP1999-11-12STANDARD
EFFICACY; EfficacySUPPL13AP1999-01-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1998-10-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1999-12-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-01-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2000-11-07STANDARD
LABELING; LabelingSUPPL20AP2002-07-12STANDARD
LABELING; LabelingSUPPL21AP2002-07-15STANDARD
LABELING; LabelingSUPPL24AP2004-02-06STANDARD
LABELING; LabelingSUPPL25AP2004-01-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2004-10-21STANDARD
LABELING; LabelingSUPPL28AP2005-11-22STANDARD
LABELING; LabelingSUPPL29AP2006-05-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL35AP2013-05-16STANDARD
LABELING; LabelingSUPPL36AP2014-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL37AP2015-11-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL38AP2016-01-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL39AP2016-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL40AP2016-05-09STANDARD
LABELING; LabelingSUPPL41AP2016-05-10STANDARD
LABELING; LabelingSUPPL42AP2016-07-06STANDARD
LABELING; LabelingSUPPL43AP2016-07-05STANDARD
LABELING; LabelingSUPPL45AP2017-07-23STANDARD
LABELING; LabelingSUPPL49AP2018-06-27STANDARD
LABELING; LabelingSUPPL51AP2019-01-02STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL14Null0
SUPPL15Null0
SUPPL17Null0
SUPPL18Null0
SUPPL24Null9
SUPPL27Null0
SUPPL35Null0
SUPPL36Null6
SUPPL37Null0
SUPPL38Null0
SUPPL39Null0
SUPPL40Null0
SUPPL41Null15
SUPPL42Null6
SUPPL43Null7
SUPPL45Null6
SUPPL49Null7
SUPPL51Null7

CDER Filings

DR REDDYS LABS SA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20076
            [companyName] => DR REDDYS LABS SA
            [docInserts] => ["",""]
            [products] => [{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"7MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"14MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"21MG\/24HR","dosageForm":"Film, Extended Release; Transdermal","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"7MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"14MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"No"},{"drugName":"HABITROL","activeIngredients":"NICOTINE","strength":"21MG\/24HR","dosageForm":"FILM, EXTENDED RELEASE;TRANSDERMAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/02\/2019","submission":"SUPPL-51","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020076Orig1s051lbl.pdf\"}]","notes":""},{"actionDate":"06\/27\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020076Orig1s049lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020076Orig1s045lbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/2017","submission":"SUPPL-45","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020076Orig1s045lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2016","submission":"SUPPL-42","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020076Orig1s042lbl.pdf\"}]","notes":""},{"actionDate":"07\/05\/2016","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020076Orig1s043lbl.pdf\"}]","notes":""},{"actionDate":"05\/10\/2016","submission":"SUPPL-41","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/20076Orig1s041Lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2014","submission":"SUPPL-36","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020076Orig1s036lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2002","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20076s21lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2002","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20076s20lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"7MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"14MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"21MG\/24HR","submissionClassification":"Film, Extended Release; Transdermal","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"7MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"14MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"},{"actionDate":"HABITROL","submission":"NICOTINE","actionType":"21MG\/24HR","submissionClassification":"FILM, EXTENDED RELEASE;TRANSDERMAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-02
        )

)
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