TEVA WOMENS FDA Approval NDA 011522

NDA 011522

TEVA WOMENS

FDA Drug Application

Application #011522

Documents

Letter2002-11-08
Letter2005-08-04
Letter2006-07-27
Letter2006-07-27
Letter2007-06-14
Letter2015-10-06
Label2005-08-04
Label2006-07-27
Label2015-10-07
Letter2005-08-04
Letter2015-04-20
Label2005-08-04
Label2006-07-27
Label2007-06-12
Label2015-04-19
Review2000-06-12
Review2004-04-14
Medication Guide2015-10-23
Other Important Information from FDA2007-05-31
Label2017-01-06
Letter2017-01-09
Letter2022-02-28
Label2022-03-01
Medication Guide2022-03-01

Application Sponsors

NDA 011522TEVA WOMENS

Marketing Status

Discontinued007
Discontinued008
Discontinued009
Discontinued010
Discontinued011
Discontinued012
Discontinued013

Application Products

007TABLET;ORAL2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 10AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
008TABLET;ORAL5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 20AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
009TABLET;ORAL1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 5AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
010TABLET;ORAL7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 30AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
011TABLET;ORAL1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 7.5AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
012TABLET;ORAL3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 12.5AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
013TABLET;ORAL3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1ADDERALL 15AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

FDA Submissions

TYPE 2/4; Type 2 New Active Ingredient and Type 4 New CombinationORIG1AP1960-01-19STANDARD
LABELING; LabelingSUPPL9AP1996-02-13
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1996-02-13STANDARD
LABELING; LabelingSUPPL11AP1997-07-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1997-01-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1997-05-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1997-06-13STANDARD
LABELING; LabelingSUPPL15AP1997-07-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1997-11-14STANDARD
LABELING; LabelingSUPPL17AP1997-07-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1998-01-08STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1998-03-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1999-02-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1999-05-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1999-11-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1999-09-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2000-01-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2000-02-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2000-08-31STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2000-07-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2001-12-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2002-04-11STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL30AP2002-11-08STANDARD
LABELING; LabelingSUPPL32AP2005-08-02STANDARD
LABELING; LabelingSUPPL33AP2005-08-02STANDARD
LABELING; LabelingSUPPL34AP2006-07-26STANDARD
LABELING; LabelingSUPPL37AP2006-07-26STANDARD
LABELING; LabelingSUPPL40AP2007-06-07STANDARD
LABELING; LabelingSUPPL41AP2015-04-17901 REQUIRED
LABELING; LabelingSUPPL42AP2015-10-01STANDARD
LABELING; LabelingSUPPL43AP2017-01-04901 REQUIRED
LABELING; LabelingSUPPL44AP2022-02-25901 REQUIRED

Submissions Property Types

SUPPL10Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL29Null0
SUPPL30Null0
SUPPL41Null15
SUPPL42Null6
SUPPL43Null7
SUPPL44Null7

CDER Filings

TEVA WOMENS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11522
            [companyName] => TEVA WOMENS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/011522s044lbl.pdf#page=15"]
            [products] => [{"drugName":"ADDERALL 10","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 12.5","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 15","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 20","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 30","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 5","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ADDERALL 7.5","activeIngredients":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","strength":"1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/25\/2022","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/011522s044lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-43","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/011522s043lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2015","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/011522s042lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/011522s041lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2007","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/011522s040lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2006","submission":"SUPPL-37","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/011522s034s037,021303s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2006","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/011522s034s037,021303s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2005","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/011522s032,033lbl.pdf\"}]","notes":""},{"actionDate":"08\/02\/2005","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/011522s032,033lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADDERALL 10","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 12.5","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 15","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 20","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 30","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 5","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ADDERALL 7.5","submission":"AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE","actionType":"1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-02-25
        )

)
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