PFIZER INC FDA Approval NDA 020287

NDA 020287

PFIZER INC

FDA Drug Application

Application #020287

Documents

Letter1999-03-30
Letter2003-03-10
Letter2000-08-03
Letter2002-04-04
Letter2002-11-01
Letter2003-07-06
Letter2004-04-29
Letter2007-05-07
Label2015-01-30
Review2008-08-11
Review1998-02-04
Review1999-03-30
Review2007-07-06
Review2007-07-06
Letter1999-05-25
Letter2002-04-04
Letter2002-04-04
Letter2002-11-19
Letter2003-12-16
Letter2010-01-05
Letter2010-10-26
Letter2015-01-27
Letter2015-10-01
Label1999-03-30
Label1999-05-25
Label2000-08-03
Label2003-12-16
Label2007-05-07
Label2009-12-30
Label2010-10-25
Label2015-10-07
Review1999-05-25
Review2008-08-01
Review2008-08-01
Review2008-07-31
Review2012-03-27
Letter2016-08-04
Label2016-08-04
Label2017-05-12
Letter2017-05-17
Label2019-05-16
Letter2019-05-17
Pediatric Other1900-01-01
Letter2020-06-30
Letter2020-06-30
Label2020-07-02
Label2020-07-02
Letter2020-12-08
Label2020-12-09

Application Sponsors

NDA 020287PFIZER INC

Marketing Status

Prescription001
Discontinued002
Prescription003
Prescription004
Prescription005
Prescription006
Discontinued007
Discontinued008
Prescription009
Prescription010
Prescription011
Prescription012

Application Products

001INJECTABLE;SUBCUTANEOUS2,500IU/0.2ML (12,500IU/ML)1FRAGMINDALTEPARIN SODIUM
002INJECTABLE;SUBCUTANEOUS10,000IU/0.4ML (25,000IU/ML)0FRAGMINDALTEPARIN SODIUM
003INJECTABLE;SUBCUTANEOUS5,000IU/0.2ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
004INJECTABLE;SUBCUTANEOUS10,000IU/ML (10,000IU/ML)1FRAGMINDALTEPARIN SODIUM
005INJECTABLE;SUBCUTANEOUS7,500IU/0.3ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
006INJECTABLE;SUBCUTANEOUS95,000IU/3.8ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
007INJECTABLE;SUBCUTANEOUS95,000IU/9.5ML (10,000IU/ML)0FRAGMINDALTEPARIN SODIUM
008INJECTABLE;INJECTION7,500 IU/0.75ML0FRAGMINDALTEPARIN SODIUM
009INJECTABLE;SUBCUTANEOUS12,500IU/0.5ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
010INJECTABLE;SUBCUTANEOUS15,000IU/0.6ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
011INJECTABLE;SUBCUTANEOUS18,000IU/0.72ML (25,000IU/ML)1FRAGMINDALTEPARIN SODIUM
012INJECTABLE;SUBCUTANEOUS10,000IU/4ML (2,500IU/ML)1FRAGMINDALTEPARIN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP1994-12-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-03-18STANDARD
EFFICACY; EfficacySUPPL3AP1996-03-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-04-08STANDARD
LABELING; LabelingSUPPL5AP1996-09-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-01-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1997-01-23STANDARD
EFFICACY; EfficacySUPPL8AP1999-03-30STANDARD
LABELING; LabelingSUPPL9AP1998-01-30STANDARD
EFFICACY; EfficacySUPPL10AP1999-05-25STANDARD
LABELING; LabelingSUPPL11AP2003-02-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1999-01-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1999-08-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1999-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2000-11-14STANDARD
EFFICACY; EfficacySUPPL18AP2000-08-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2001-09-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL21AP2002-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2002-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2002-04-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2002-03-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2001-06-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL26AP2002-04-26STANDARD
LABELING; LabelingSUPPL27AP2002-11-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL28AP2002-09-11STANDARD
LABELING; LabelingSUPPL29AP2002-11-19STANDARD
LABELING; LabelingSUPPL31AP2003-06-30STANDARD
EFFICACY; EfficacySUPPL32AP2003-12-10STANDARD
LABELING; LabelingSUPPL34AP2004-04-21STANDARD
EFFICACY; EfficacySUPPL35AP2007-05-01UNKNOWN
LABELING; LabelingSUPPL49AP2009-12-23STANDARD
LABELING; LabelingSUPPL50AP2010-10-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL59AP2013-09-27STANDARD
LABELING; LabelingSUPPL60AP2013-10-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL61AP2013-10-22STANDARD
LABELING; LabelingSUPPL62AP2015-01-27STANDARD
LABELING; LabelingSUPPL63AP2015-09-29STANDARD
LABELING; LabelingSUPPL67AP2016-08-04STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL68AP2017-01-26STANDARD
LABELING; LabelingSUPPL69AP2017-05-12STANDARD
EFFICACY; EfficacySUPPL72AP2019-05-16PRIORITY
LABELING; LabelingSUPPL74AP2020-06-26STANDARD
LABELING; LabelingSUPPL75AP2020-06-26STANDARD
LABELING; LabelingSUPPL76AP2020-12-05STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL12Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0
SUPPL26Null0
SUPPL28Null0
SUPPL49Null7
SUPPL50Null31
SUPPL59Null0
SUPPL60Null0
SUPPL61Null0
SUPPL62Null15
SUPPL63Null6
SUPPL67Null7
SUPPL69Null7
SUPPL72Null6
SUPPL74Null15
SUPPL75Null6
SUPPL76Null6

CDER Filings

PFIZER INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20287
            [companyName] => PFIZER INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"2,500IU\/0.2ML (12,500IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"10,000IU\/0.4ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"5,000IU\/0.2ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"10,000IU\/ML (10,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"7,500IU\/0.3ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"95,000IU\/3.8ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"95,000IU\/9.5ML (10,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"7,500 IU\/0.75ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"12,500IU\/0.5ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"15,000IU\/0.6ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FRAGMIN","activeIngredients":"DALTEPARIN SODIUM","strength":"18,000IU\/0.72ML (25,000IU\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/26\/2020","submission":"SUPPL-75","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020287s074s075lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2020","submission":"SUPPL-74","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020287s074s075lbl.pdf\"}]","notes":""},{"actionDate":"05\/16\/2019","submission":"SUPPL-72","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020287s072lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2017","submission":"SUPPL-69","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020287s069lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2016","submission":"SUPPL-67","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020287s067lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2015","submission":"SUPPL-63","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020287s063lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2015","submission":"SUPPL-62","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020287s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2010","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020287s050lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2009","submission":"SUPPL-49","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020287s049lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2007","submission":"SUPPL-35","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/020287s035lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2003","submission":"SUPPL-32","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20287se1-032_fragmin_lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2000","submission":"SUPPL-18","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20287S18LBL.PDF\"}]","notes":""},{"actionDate":"05\/25\/1999","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/020287S10_Fragmin_prntlbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/1999","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20287s8lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"2,500IU\/0.2ML (12,500IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"10,000IU\/0.4ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"5,000IU\/0.2ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"10,000IU\/ML (10,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"7,500IU\/0.3ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"95,000IU\/3.8ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"95,000IU\/9.5ML (10,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"7,500 IU\/0.75ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"12,500IU\/0.5ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"15,000IU\/0.6ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"FRAGMIN","submission":"DALTEPARIN SODIUM","actionType":"18,000IU\/0.72ML (25,000IU\/ML)","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-06-26
        )

)
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