PAR STERILE PRODUCTS FDA Approval NDA 204485

NDA 204485

PAR STERILE PRODUCTS

FDA Drug Application

Application #204485

Documents

Letter2014-04-18
Letter2015-05-07
Label2014-09-03
Label2015-01-07
Label2015-05-07
Review2015-01-28
Summary Review2015-01-28
Label2017-04-12
Label2017-04-12
Review2017-05-17
Review2017-06-29
Letter2019-05-15
Label2019-05-17
Letter2020-02-25
Label2020-02-27
Label2020-07-30
Letter2020-07-30
Letter2021-03-16
Label2021-03-29
Letter2021-03-30
Label2021-04-09
Letter2021-04-09
Letter2021-07-21
Label2021-07-21
Letter2022-09-27
Label2022-09-27
Letter2022-11-25
Label2022-11-27
Letter2022-12-07
Label2022-12-08

Application Sponsors

NDA 204485PAR STERILE PRODUCTS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005

Application Products

001SOLUTION;INTRAVENOUS20UNITS/ML (20UNITS/ML)1VASOSTRICTVASOPRESSIN
002SOLUTION;INTRAVENOUS200UNITS/10ML (20UNITS/ML)1VASOSTRICTVASOPRESSIN
003SOLUTION;INTRAVENOUS40UNITS/100ML (0.4UNITS/ML)1VASOSTRICTVASOPRESSIN
004SOLUTION;INTRAVENOUS60UNITS/100ML (0.6UNITS/ML)1VASOSTRICTVASOPRESSIN
005SOLUTION;INTRAVENOUS20UNITS/100ML (0.2UNITS/ML)1VASOSTRICTVASOPRESSIN

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDAORIG1AP2014-04-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2015-05-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2016-03-21STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2016-12-17STANDARD
LABELING; LabelingSUPPL9AP2019-05-14STANDARD
LABELING; LabelingSUPPL11AP2021-03-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2020-04-15STANDARD
LABELING; LabelingSUPPL14AP2020-02-21STANDARD
LABELING; LabelingSUPPL17TA2020-10-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2021-04-21N/A
LABELING; LabelingSUPPL25AP2022-09-14STANDARD
LABELING; LabelingSUPPL26AP2022-11-22STANDARD
LABELING; LabelingSUPPL27AP2022-12-06STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null0
SUPPL3Null0
SUPPL9Null7
SUPPL11Null6
SUPPL14Null7
SUPPL17Null15
SUPPL25Null15
SUPPL26Null15
SUPPL27Null15

TE Codes

001PrescriptionAP

CDER Filings

PAR STERILE PRODUCTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204485
            [companyName] => PAR STERILE PRODUCTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VASOSTRICT","activeIngredients":"VASOPRESSIN","strength":"20UNITS\/ML (20UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VASOSTRICT","activeIngredients":"VASOPRESSIN","strength":"200UNITS\/10ML (20UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VASOSTRICT","activeIngredients":"VASOPRESSIN","strength":"40UNITS\/100ML (0.4UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"VASOSTRICT","activeIngredients":"VASOPRESSIN","strength":"60UNITS\/100ML (0.6UNITS\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/15\/2020","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204485Orig1s013lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"02\/21\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204485s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204485s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204485s004lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"03\/21\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204485s003lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"05\/07\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204485Orig1s002lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/18\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204485Orig1s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"04\/17\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204485Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/17\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204485Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204485Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204485Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204485Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/21\/2020","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204485s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204485Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"04\/15\/2020","submission":"SUPPL-13","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204485Orig1s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204485Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/204485s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/204485Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/17\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204485s004lbl.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/204485Orig1s004.pdf\"}]","notes":">"},{"actionDate":"03\/21\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/204485s003lbl.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/2044850Orig1s003.pdf\"}]","notes":">"},{"actionDate":"05\/07\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/204485Orig1s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/204485Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"09\/18\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204485Orig1s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-15
        )

)
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